104 results
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36ms
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Sources: EU EUDAMED, US FDA
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 15, 2013
Phoenix AP AST Indicator Bag, Catalog Number 246006
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2019
Phoenix AST Indicator, Catalog Number 246004
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 25, 2012
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2019
Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 21, 2018
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
BD AffirM VPIII Microbial Identification Test
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 8, 2017
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 29, 2018
Phoenix AST-s Indicator, Catalog Number 246009
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·March 6, 2019
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·January 29, 2014
PrepStain AG. For use in the screening and detection of cervical cancer.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 4, 2013
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 25, 2012
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·September 4, 2013
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 24, 2015
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2013
BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·May 22, 2013