BIOMERIEUX SA

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

  2023-03-09

  Biomerieux Sa, Inc.

• VIDAS NEPHROCHECK

  2022-07-08

  BioMérieux SA

• ETEST Fosfomycin (FO) (0.032-512 µg/mL)

  2021-11-12

  BioMerieux SA

• ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

  2019-11-26

  BioMerieux SA

• ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

  2019-09-27

  BioMerieux SA

• ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 Ug/mL)

  2019-08-22

  BioMerieux SA

• ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 Ug/mL)

  2019-05-01

  BioMerieux SA

• ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

  2019-01-11

  BioMerieux SA

• CHROMID CARBA Agar (CARB)

  2018-07-06

  BioMerieux SA

• ETEST Telavancin (TLA) (0.002-32 Ug/mL)

  2018-07-03

  BioMerieux SA

• RAPIDEC CARBA NP

  2017-04-27

  BIOMERIEUX SA

• Etest Ceftaroline (0.002 - 32ug/ml)

  2015-10-07

  BIOMERIEUX SA

• VIDAS FT4

  2015-06-08

  BIOMERIEUX SA

• VIDAS C DIFFICILE GDH

  2013-10-09

  BIOMERIEUX SA

• VIDAS LYME IGM

  2013-06-04

  BIOMERIEUX SA

• VIDAS LYME IGG

  2013-03-05

  BIOMERIEUX SA

• ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

  2011-05-16

  BIOMERIEUX SA

GUDID#

• VIDAS® Measles IgG - VIDAS Measles IgG (MSG) assay is a qualitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.

  BIOMERIEUX SA

  2019-08-30

• VIDAS® Varicella-Zoster IgG - VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum.

  BIOMERIEUX SA

  2016-08-31

• VITEK®MS - DVD to install VITEK MS SW v1.0 and VITEK MS FlexPrep v1.0 for clinical customers

  BIOMERIEUX SA

  2019-04-30

• VIDAS® Varicella-Zoster IgG - VIDAS VARICEL. ZOSTER IGG assay is a qualitative IA intended for use on VIDAS family instrument for the detection of IgG antibodies to Varicella Zoster in human serum.

  BIOMERIEUX SA

  2026-01-19

• ETEST® Tigecycline (TGC) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-12-12

• ID color Catalase - Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems.

  BIOMERIEUX SA

  2019-07-19

• ID color Catalase - Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems.

  BIOMERIEUX SA

  2019-07-19

• THxID™ BRAF - Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

  BIOMERIEUX SA

  2017-05-12

• VIDAS® Quality Control - Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems.

  BIOMERIEUX SA

  2019-11-19

• ASTUTE140 Electronic Quality Control (EQC) Device - 400016

  BIOMERIEUX SA

  2016-08-12

• NEPHROCHECK Calibration Verification (Cal Vers) Kit - The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System.

  BIOMERIEUX SA

  2016-08-12

• NEPHROCHECK Test Kit - The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.

  BIOMERIEUX SA

  2016-08-12

• NEPHROCHECK Liquid Control Kit - The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System.

  BIOMERIEUX SA

  2016-08-12

• ETEST® Ertapenem (ETP) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Tobramycin (TM) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Tigecycline (TGC) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Ampicillin/sulbactam (2/1) (AB) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Tetracycline (TC) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Fosfomycin (FM) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Ceftaroline (CPT) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2016-11-18

• ETEST® Telavancin (TLA) - Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

  BIOMERIEUX SA

  2019-01-28

• API® M Medium - API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip.

  BIOMERIEUX SA

  2020-04-10

• CHROMID® P. aeruginosa Agar - Direct identification of Pseudomonas aeruginosa in pulmonary specimens.

  BIOMERIEUX SA

  2020-05-19

• CHROMID® Candida Agar - Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans

  BIOMERIEUX SA

  2020-05-19

• CHROMID® C. difficile - Chromogenic medium for the detection and ident ification of Clostridium difficile.

  BIOMERIEUX SA

  2020-05-19

• ETEST® Ampicillin/Sulbactam (2/1) (AB) - ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria

  BIOMERIEUX SA

  2022-04-05

• CHROMID® P. aeruginosa Agar - Direct identification of Pseudomonas aeruginosa in pulmonary specimens.

  BIOMERIEUX SA

  2020-05-19

• CHROMID® Candida Agar - Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans

  BIOMERIEUX SA

  2020-05-19

• CHROMID® C. difficile - Chromogenic medium for the detection and ident ification of Clostridium difficile.

  BIOMERIEUX SA

  2020-05-19

• Todd Hewitt Broth + Antibiotics - selective enrichment broth for the detection of group B streptococci in pregnant women.

  BIOMERIEUX SA

  2019-07-22

• CHROMID® MRSA / CHROMID S. aureus - Chromogenic medium for the screening and qualitative detection of methicillin-resistant Staphylococcus aureus and selective isolation of staphylococci and the direct identification of S. aureus.

  BIOMERIEUX SA

  2016-09-16

• API® NaCl 0.85% Medium - NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.

  BIOMERIEUX SA

  2020-04-10

• API® NaCl 0.85% Medium - NaCl 0.85 % Medium and Suspension Medium are designed to be used as suspension media with API ®, ID 32 or ATB™ products.

  BIOMERIEUX SA

  2020-04-10

• API® 20 E - API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gramnegative rods

  BIOMERIEUX SA

  2020-04-10

• CHROMID® Salmonella Elite - chromID™ Salmonella Eliteagar is a chromogenic medium for the selective isolation and identification of Salmonellain human specimens (stools)

  BIOMERIEUX SA

  2020-05-19

• CHROMID® CPS® Elite Agar (CPSE) - Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms

  BIOMERIEUX SA

  2020-05-19

• CHROMID® CPS® Elite Agar (CPSO) - Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms

  BIOMERIEUX SA

  2020-05-19

• CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood - This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens

  BIOMERIEUX SA

  2020-05-19

• CHROMID® S. aureus Elite agar - Selective isolation and direct identification of Staphylococcus aureus

  BIOMERIEUX SA

  2020-05-19

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