| 13 Mar 2020 | Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 2 |
| 12 Mar 2020 | Red Clover 4 oz, Red Clover 2 Lbs. Products have Red Clover as an ingredient. | Chicago Indoor Garden, Inc. | Food | Class I | 4 |
| 11 Mar 2020 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 10 Mar 2020 | Juanita's Foods Hot & Spicy Menudo; Picoso; 25 oz.( 1 lb. 9oz.) 709 grams UPC: 70132 00201 Juanita's Foods, Wilmington, CA (85199) | Juanita's Foods Inc. | Food | Class II | 1 |
| 10 Mar 2020 | Pero Family Farms Fresh n' Savory Simple Side Kit Zucchini Spiral Pesto; 11 oz. EXP 2020-03-20. Cooks in 5 Minutes (85182) | Individual firm, name withheld | Food | Class I | 1 |
| 9 Mar 2020 | Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 9 Mar 2020 | Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202;… | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 9 Mar 2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 9 Mar 2020 | Outshine Fruit Bars Strawberry; 6 Fruit Ice Bars; 14.7 Fl. oz. (435 mL) UPC: 041548610047 Case UPC: 10041548610044 | Dreyers Grand Ice Cream, Inc. | Food | Class II | 3 |
| 6 Mar 2020 | Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433 | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 6 Mar 2020 | HEB Tuscan Herb Chopped Salad Kit, 12.6 oz. UPC: 0-41220-40989-1 | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 5 Mar 2020 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 | Fresenius Medical Care Holdings, Inc. | Drug | Class II | 1 |
| 5 Mar 2020 | Stonewall Kitchen, Ghost Pepper Salsa, Net Weight 454g (16oz), Ingredients: Tomatoes, Jalapeno Peppers, Onion, Tomato Puree, Green Chile Peppers, Distilled Vinegar, Salt, Dehydrated Ghost Pepper, Dehydrated Garlic, Spices, Dehydrated Cilantro. UPC 7 11381 32738 8. BEST BY 23MAY2021. Packaged in 16 oz. glass jars with… | Stonewall Kitchen, LLC | Food | Class II | 1 |
| 4 Mar 2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 | Par Pharmaceutical Inc. | Drug | Class III | 1 |
| 3 Mar 2020 | Vita Wild Herring in Wine Sauce 32oz plastic jar, UPC 22635 40011, 6 jars per case Ready to Eat Keep Refrigerated | Vita Food Products, Inc. | Food | Class I | 1 |
| 2 Mar 2020 | Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3 | Noven Therapeutics, LLC | Drug | Class II | 4 |
| 2 Mar 2020 | Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01 | Mayne Pharma Inc | Drug | Class II | 1 |
| 28 Feb 2020 | Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01 (85127) | Sunstar Guangzhou Ltd. | Drug | Class II | 1 |
| 28 Feb 2020 | GREAT VALUE¿ Pure Granulated Sugar, 10 lbs. Sold as individual bags on a unitized 1/2 pallet 78 bags to a 1/2 pallet. | Domino Foods Inc | Food | Class II | 1 |
| 27 Feb 2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 | Pfizer Inc. | Drug | Class II | 1 |
| 27 Feb 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61 | The Harvard Drug Group | Drug | Class III | 4 |
| 27 Feb 2020 | Pure Cane Granulated Sugar, Single 10 lb. package, 156 paper bags on 2 1/2 CHEP pallets (85160) | Maryland Packaging, LTD. | Food | Class II | 1 |
| 27 Feb 2020 | Barts Ice Cream Co. brand of Chocolate Chip Cookie Dough ice cream (Vanilla ice cream with chunks of cookie dough and dark chocolate chips) packaged in a white pint paper container (1 pint) with expiration dates from 03/05/21 through 06/04/21 and UPC#: 048896100169. (85142) | Snow's Acquisition, LLC | Food | Class II | 1 |
| 26 Feb 2020 | HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9. | Philips North America, LLC | Device | Class II | 1 |
| 26 Feb 2020 | Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, Net Wt. 48 oz (1360g) UPC 6 98240 00412 6. Made by: Club's Choice Fundraising, Eau Claire, WI 54703 (85088) | Choice Products LLC. | Food | Class I | 1 |
| 25 Feb 2020 | Profile Food Ingredients, 10# Choc Dairy Pwd PFI-1010, packaged in 50 lb bags. | International Food Products Corporation | Food | Class II | 3 |
| 25 Feb 2020 | Meijer Chicken Cobb Salad 10.75oz. in Clear plastic, sectioned, container; UPC 71928367932 | Meijer | Food | Class II | 1 |
| 25 Feb 2020 | Butterfly Shrimp 16/20, 50 lb. cases (85055) | Les Chateaux De France | Food | Class II | 1 |
| 24 Feb 2020 | LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less. | LivaNova USA Inc. | Device | Class II | 1 |
| 24 Feb 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98. | Breckenridge Pharmaceutical, Inc | Drug | Class III | 1 |
| 24 Feb 2020 | Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901 | Redline Pharmacy Solutions | Drug | Class II | 6 |
| 24 Feb 2020 | Sierra Soups Pasta e Fagioli: All Natural Vegetarian Vegan (without pasta); Gluten Free (without pasta); Net Wt. 369 g , 13 oz. Packed in clear plastic bag. Pasta is contained in a separate plastic bag inside the package. Product of USA Sierra Foods Company, Fresno, CA 93711 (85003) | Individual firm, name withheld | Food | Class II | 1 |
| 24 Feb 2020 | Sesame Sticks packaged in clear zip tie 5 oz. bags. UPC 8 40600 11010 1. The FRONT side label is read in parts: "***NEW SEASONS ***Sesame Sticks ***". The BACK side label is read in parts: "***Wasabi Peas 840600110101 ***Ingredients: Wasabi Peas (Peas, Corn Starch, Wasabi Flavor, Sugar, Palm Oil, Sea Salt)***Produced… | New Seasons Market LLC | Food | Class II | 1 |
| 24 Feb 2020 | American Bounty brand Icing Mix Vanilla, Item #32595, in 5 lb. metallic pouches, 6 pouches per case. | Tova Industries Inc | Food | Class II | 22 |
| 24 Feb 2020 | Shearer's Yellow tortilla chips, round Mini and Restaurant sizes, packaged in clear film pillow bags in the following weights: 1oz (100 count per case), 1.5oz (72 count per case), 2oz (60 count per case), and a bulk case16oz bags (10 count per case) | Shearer'S Snacks | Food | Class I | 1 |
| 21 Feb 2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35 | Akorn, Inc. | Drug | Class III | 3 |
| 21 Feb 2020 | Michele s Granola, MOM s Salted Maple Pecan Granola, 4 Cases of 12-12 oz. stand up pouches. (85058) | Michele's Granola LLC | Food | Class II | 1 |
| 21 Feb 2020 | Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM (85052) | Cj Haide (Ningbo) Biotech Co., Ltd | Food | Class II | 1 |
| 21 Feb 2020 | Kaiser Mild Banana Pepper Rings 1/4 KK in 1 gallon plastic bottles (4 gallons per case). (85056) | Kaiser Pickles LLC | Food | Class II | 1 |
| 21 Feb 2020 | Moonstruck Praline Pecan & Ginger Element Bar in Dark Chocolate, packaged first into a clear poly film that is sealed. The sealed bar is then packed into a cardboard box (1 bar per box) that has label information. Net wt. 3.1 oz. The product SKU number is 312806 and the UPC code is 7 11175 12328 8. The product is… | Moonstruck Chocolate Company | Food | Class I | 1 |
| 20 Feb 2020 | RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system | RAYSEARCH LABORATORIES AB | Device | Class II | 7 |
| 20 Feb 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 20 Feb 2020 | Pure Dent¿ B700 Food Corn Starch packaged in 50 lb bags (85031) | Grain Processing Corporation | Food | Class II | 1 |
| 19 Feb 2020 | Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 19 Feb 2020 | Nature's Sunshine SmartMeal Nutritional Shake Mix; Natural Chocolate Flavor Net Wt. 1 lb. 3.5 oz. (555 Grams) UPC: 0 99904 03084 8 Product number: 6116 US3084 Distributed exclusively by: Nature's Sunshine Products, Inc. Spanish Fork, UT 84660 | Pro-Form Manufacturing LLC | Food | Class III | 7 |
| 18 Feb 2020 | Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. | Avid Medical, Inc. | Device | Class II | 9 |
| 18 Feb 2020 | Kroger Sweet & Mesquite BBQ potato chips -17 oz. UPC: 0-11110-03201-0 (85014) | Saratoga Potato Chips LLC | Food | Class I | 1 |
| 18 Feb 2020 | Paleonola Grain Free Granola; The Original; packaged in 10oz stand-up pouches; UPC 013964497144 | Paleonola Llc | Food | Class III | 6 |
| 17 Feb 2020 | Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08 (84968) | Strides Pharma Science Limited | Drug | Class III | 1 |
| 14 Feb 2020 | Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 14 Feb 2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211… | AAA Pharmaceutical, Inc. | Drug | Class III | 1 |
| 14 Feb 2020 | Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked Hokkien Noodles - Sweet & Tangy sauce with Bok choy and carrots. Noodles are in Opaque White Plastic bowl with paper sleeves. Net Wt. 7.8 oz. (221g) UPC: 7-65667-10387-6 Add 1 1/4 water and microwave on high for 90 seconds on high. Distributed by: CJ Foods… (85005) | CJ Foods Inc., A Division of CJ America | Food | Class II | 1 |
| 14 Feb 2020 | Sticky Fingers Bakeries Gluten-Free Scones, Quick & Easy Mix, Meyer Lemon; Net Wt. 14 oz. (0.875 LBS) 396.9g. In Ingredient list: Lemon Flavored Pieces {sugar, enriched wheat flour (wheat flour, niacin, reduced iron Thiamin mononitrate, riboflavin, folic acid) Sticky Fingers Bakeries, Santa Fe Springs, CA Product of… (85101) | Custom Foods LLC | Food | Class III | 1 |
| 13 Feb 2020 | Original El Milagro Corn/Maiz tortillas 30 count Net Wt. 26 Oz. (750g) Refrigerate After Purchase UPC 649619621178 (85021) | El Milagro of Texas Inc. | Food | Class II | 1 |
| 13 Feb 2020 | C&H Pure Cane Sugar Golden Brown, 32 oz (2 LB) plastic bag, UPC 015800090038, Lots 50042 (Best By Jan 21, 2022) & 50043 (Best By Jan 22, 2022) | Domino Foods Inc | Food | Class II | 8 |
| 12 Feb 2020 | Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse… | Boston Scientific Corporation | Device | Class II | 2 |
| 12 Feb 2020 | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes. | Nextremity Solutions | Device | Class II | 1 |
| 12 Feb 2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012 | Golden State Medical Supply Inc. | Drug | Class III | 1 |
| 12 Feb 2020 | Lotte Choco Pie Cocao, 12 pack, 11.85 oz. (336 g) UPC: 8 801062 475148 Distributed by Lotte International America, Los Angeles, CA Product of Korea | Lotte Int'l America Corp. | Food | Class II | 3 |
| 12 Feb 2020 | Deep-fried Donut (Banh Tieu) 3.2-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH TIEU***Ingredients: bread flour, sugar, baking powder, salt, sesame seed, water, shortening oil.***Lanvin French Bakery***". | Lanvin French Bakery, LLC | Food | Class II | 2 |
| 12 Feb 2020 | Coburn Farms Snackers, Sharp Yellow Cheddar Cheese, Cherry Juice Infused Dried Cranberries & Roasted Sea Salted Cashews, 3 Pack, Net Wt 4.5 oz (127.5g) 3-1.5 oz (42.5g) packs, Keep Refrigerated. UPC 51933-36243. Distributed By: Save-A-Lot Food Stores, Ltd., Earth City, MO 63045 | Great Lakes Cheese Co Inc | Food | Class II | 1 |
| 11 Feb 2020 | Donor human milk in 3 oz. plastic bottles. (85032) | Mothers' Milk Bank of Louisiana at Ochsner Baptist | Food | Class II | 1 |
| 11 Feb 2020 | PREMIUM SELECTIONS BANANA PUDDING ICE CREAM NATURALLY & ARTIFICIALLY FLAVORED 1.5 QUART (1.42 L) KEEP FROZEN CONTAINS: MILK, WHEAT, COCONUT OIL, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 877-533-2767 UPC 0 72036 43031 1 | Harris Teeter Supermarkets, LLC dba Hunter Farms | Food | Class II | 1 |
| 10 Feb 2020 | AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications (85028) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Feb 2020 | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934 | Covidien Llc | Device | Class II | 2 |
| 10 Feb 2020 | Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203 | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 10 Feb 2020 | Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Feb 2020 | Blendtopia Superfood Smoothie Kit Glow flavor, 7 oz flexible pouch | Blendtopia Products, LLC | Food | Class I | 5 |
| 10 Feb 2020 | Siete Grain Free Burrito Size Tortillas Net Wt 15 oz (423g) 6 count UPC 865336000083 packaged in flexible plastic (84958) | GARZA FOOD VENTURES | Food | Class II | 1 |
| 8 Feb 2020 | Driscoll's Raspberries- 6 oz. clamshell container 12 x 6 oz. per crate and 6 x 12 x 6 oz. (2 - 6 oz. attached clamshells) per crate UPC: 7 15756 10001 9 Product of Mexico | Driscoll's Inc. | Food | Class III | 1 |
| 7 Feb 2020 | Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 7 Feb 2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. | Integra LifeSciences Corp. | Device | Class III | 1 |
| 7 Feb 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class I | 1 |
| 7 Feb 2020 | Natural Grocers Organic Extra Virgin Coconut Oil, packaged in glass jars with metal lids and a plastic shrink seal, 17.5 oz. (518 mL), UPC# 849327-000368, Vitamin Cottage Natural Foods Markets (dba Natural Grocers) Lakewood, CO 80228. 12 units (jars)/case in cardboard box. | Vitamin Cottage Natural Food Markets, Inc. | Food | Class II | 2 |
| 7 Feb 2020 | Foodservice item, Norpac Catalog Number 08099, frozen FLAV-R-PAC Roasted Spicy Potatoes O'brien, 6/40 oz. (2.5 lbs.) clear poly bags per case. Master Case # 100488000080997. The affected product was packaged in a clear poly bags and has no label. The affected product's master case white label is read in parts:… (84921) | PNW Veg Co LLC | Food | Class I | 1 |
| 7 Feb 2020 | Lindt Excellence 85% Cocoa Dark Chocolate Bars, 3.5 oz.(100g) (84920) | Lindt & Sprungli (USA), Inc. | Food | Class II | 1 |
| 6 Feb 2020 | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | Invivo Corporation | Device | Class II | 1 |
| 6 Feb 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures. | Deroyal Industries, Inc. Lafollette | Device | Class II | 1 |
| 5 Feb 2020 | IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 4 Feb 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12; | Deroyal Industries, Inc. Lafollette | Device | Class II | 10 |
| 4 Feb 2020 | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) | CareFusion 303, Inc. | Device | Class I | 4 |
| 4 Feb 2020 | Chocolate Fudge Mini Bundt Cake sold by the slice packaged in Self Serve and Plastic clam shell containers PLU 21287 | Whole Foods Market | Food | Class I | 4 |
| 3 Feb 2020 | TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 | Individual firm, name withheld | Device | Class II | 2 |
| 30 Jan 2020 | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the… (84880) | Organ Recovery Systems, Inc. | Device | Class II | 1 |
| 30 Jan 2020 | Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 2 |
| 29 Jan 2020 | Nopalina Flax Seed Fiber in 1 and 2 lb bags, UPC 8 90523 00072 0 and 8 90523 00084 3 | Salud Natural Entrepreneur, Inc. | Food | Class I | 2 |
| 29 Jan 2020 | chef's recipe MUSHROOM BARLEY SOUP NET WT 16 OZ (1LB) 454g PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 UPC 1 61088 80363 0 | Bakkavor Foods USA Inc. | Food | Class I | 1 |
| 28 Jan 2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays. | Qiagen Sciences LLC | Device | Class II | 1 |
| 28 Jan 2020 | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560… | Medicrea International | Device | Class II | 2 |
| 28 Jan 2020 | McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy… (84819) | Medtronic, PLC | Device | Class II | 1 |
| 28 Jan 2020 | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in… | Breas Medical, Inc. | Device | Class II | 1 |
| 28 Jan 2020 | Sunny Select Au Jus Gravy Mix 1 OZ pouch (24 pouches per case) | McCormick & Company, Inc. - Flavor Manufacturing Center | Food | Class I | 1 |
| 27 Jan 2020 | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty. | Exactech, Inc. | Device | Class II | 1 |
| 24 Jan 2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487; Manufactured by: Piramal Enterprises Limited Plot No 67-70, Sector -2 Pithampur 454 775, Dist, Dhar Madhya Pradesh,… | Breckenridge Pharmaceutical, Inc | Drug | Class II | 2 |
| 24 Jan 2020 | 1. Boars Head Fresh Mozzarella Ball, 8oz. 2. Losurdo Fresh Caprese Log Mozzarella, 6 lbs. 3. Piancone Fresh Mozzarella Loaf, 3 lbs. and 6 lbs. (84793) | Losurdo Foods, Inc. | Food | Class II | 1 |
| 23 Jan 2020 | HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent… | Heartware, Inc. | Device | Class I | 2 |
| 22 Jan 2020 | Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330 | St Jude Medical, Cardiac Rhythm Management Division | Device | Class II | 1 |
| 22 Jan 2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only | Braemar Manufacturing, LLC | Device | Class II | 2 |
| 21 Jan 2020 | Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180 | Medline Industries Inc | Device | Class II | 2 |
| 21 Jan 2020 | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, | Hologic, Inc. | Device | Class II | 1 |
| 21 Jan 2020 | PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual… | Polymer Technology Systems, Inc. | Device | Class II | 1 |
| 21 Jan 2020 | Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free… | Aesculap Implant Systems LLC | Device | Class II | 5 |
| 19 Jan 2020 | Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a point-of-care solution with the… | EHOB, Inc. | Device | Class II | 1 |
| 16 Jan 2020 | Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. | Cook Inc. | Device | Class II | 1 |
| 16 Jan 2020 | COHERENCE Oncologist, Model Nos. 07333680 & 07351898 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 16 Jan 2020 | Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods. | Maquet Cardiovascular Us Sales, Llc | Device | Class III | 2 |
| 15 Jan 2020 | Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin. | Cardinal Health 200, LLC | Device | Class II | 4 |
| 15 Jan 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2 | Individual firm, name withheld | Drug | Class II | 63 |
| 14 Jan 2020 | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. | Philips North America, LLC | Device | Class II | 1 |
| 14 Jan 2020 | Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures. | Medtronic CoreValve LLC | Device | Class II | 2 |
| 13 Jan 2020 | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration -… | Philips North America, LLC | Device | Class II | 1 |
| 12 Jan 2020 | Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 10 Jan 2020 | NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens. (84766) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Jan 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | Tosoh Bioscience Inc | Device | Class II | 1 |
| 10 Jan 2020 | CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343 | Biomet 3i, LLC | Device | Class II | 23 |
| 8 Jan 2020 | Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S | Cordis Corporation | Device | Class II | 1 |
| 8 Jan 2020 | terra ingredients - Organic Gold Flax and Organic Brown Flax, 50 pound bags & 2,000 lbs. Totes (85035) | Terra Ingredients, LLC | Food | Class II | 1 |
| 7 Jan 2020 | THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 7 Jan 2020 | CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress | CME America, LLC | Device | Class I | 1 |
| 6 Jan 2020 | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 3 Jan 2020 | Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the… | Zimmer Surgical Inc | Device | Class II | 1 |
| 3 Jan 2020 | Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. | Bard Peripheral Vascular Inc | Device | Class II | 4 |
| 31 Dec 2019 | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw | ulrich medical USA Inc | Device | Class II | 1 |
| 30 Dec 2019 | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator. | Philips North America, LLC | Device | Class II | 9 |
| 20 Dec 2019 | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as acute pancreatitis and obstruction of the pancreatic duct. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Dec 2019 | LEGION PS High Flex XLPE size 5-6 9mm Articular Insert | Smith & Nephew, Inc. | Device | Class II | 1 |
| 19 Dec 2019 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. | Randox Laboratories, Limited | Device | Class II | 1 |
| 25 Nov 2019 | bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the… | Vyaire Medical | Device | Class II | 1 |
| 22 Nov 2019 | MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V,… | Microvention, Inc. | Device | Class II | 16 |
| 20 Nov 2019 | Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11 | American Health Packaging | Drug | Class II | 1 |
| 15 Nov 2019 | Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L | Baxter Healthcare Corporation | Device | Class II | 1 |
| 13 Nov 2019 | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080 | Precision Dose Inc. | Drug | Class II | 1 |
| 8 Nov 2019 | UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com. | Med Man Distribution, Inc. | Drug | Class I | 2 |
| 6 Nov 2019 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 23 Oct 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC… | Perrigo Company PLC | Drug | Class II | 17 |
| 1 Oct 2019 | Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation. | Arthrex, Inc. | Device | Class II | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Theralase Inc. | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Theralase Inc. | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Theralase Inc. | Device | Class III | 1 |
| 16 Sep 2019 | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously. | CME America, LLC | Device | Class I | 1 |
| 12 Sep 2019 | Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip,… | Stryker Corporation | Device | Class II | 2 |
| 22 Aug 2019 | Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI:… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Device | Class II | 1 |
| 20 Aug 2019 | FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only (84887) | Individual firm, name withheld | Device | Class III | 1 |
| 19 Aug 2019 | RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway. (84859) | RESPIRATORY THERAPEUTICS GROUP LLC | Device | Class II | 1 |
| 15 Aug 2019 | Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems | Normand-Info S.A.S.U. | Device | Class II | 1 |
| 15 Aug 2019 | Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733 | Beckman Coulter Inc | Device | Class II | 5 |
| 8 Aug 2019 | FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 5 Aug 2019 | Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards). | RemedyRepack Inc. | Drug | Class II | 1 |
| 3 Jul 2019 | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood. | LivaNova USA Inc. | Device | Class III | 1 |
| 19 Jun 2019 | Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009 (84817) | Seca | Device | Class II | 1 |
| 3 May 2019 | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0cc. UDI: 00849777003681 - Product Usage: OsteoSelect DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not… | XTANT MEDICAL INC | Device | Class II | 1 |
| 23 Apr 2019 | Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimally invasive and open-field imaging… | Stryker Corporation | Device | Class II | 1 |
| 4 Apr 2019 | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a… | Advanced Bionics, LLC | Device | Class III | 1 |
| 31 Mar 2019 | GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03 | Verathon, Inc. | Device | Class II | 1 |
| 15 Mar 2019 | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform. (84514) | Response Biomedical Corp. | Device | Class II | 1 |
| 18 Feb 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use… | TeDan Surgical Innovations LLC | Device | Class II | 4 |
| 12 Aug 2018 | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum.… | The Binding Site Group, Ltd. | Device | Class II | 1 |