VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
Biomerieux Sa, Inc.
BIOMERIEUX SA
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8020790 | 1000611339 | BIOMERIEUX SA | 1 | N | 2026-01-01 | CHEMIN DE L ORME MARCY L ETOILE Rhone FR 69280 |
| 9615778 | 1000351505 | BioMerieux SA | 1 | N | 2026-01-01 | PARC TECHNOLOGIQUE DELTA SUD VERNIOLLE Ariege FR 09340 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9764 | 1537244710 | K993319 | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 | LGD | 2000-05-22 |
| 148374 | 1525569376 | K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | GQH | 1998-12-14 |
| 9764 | 1770102084 | K965084 | VIDAS PROESTERONE (PRG) (30 409) | JLS | 1997-01-09 |
| 9764 | 1745557297 | K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | CHP | 1996-02-06 |
| 9764 | 1379022031 | K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | CFT | 1994-11-02 |
| 9764 | 1450844303 | K933549 | VIDAS CMV IGM ASSAY | LKQ | 1994-08-02 |
| 9764 | 1611155107 | K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | JFT | 1993-07-27 |
| 9764 | 1423114172 | K926393 | VIDAS THYROXINE (T4) ASSAY (T4) | KLI | 1993-05-13 |
| 9764 | 1269410502 | K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | LJY | 1993-08-09 |
| 9764 | 1002959347 | K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY | LGD | 1993-02-25 |
| 9764 | 1281385715 | K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | LFY | 1992-10-26 |
| 9764 | 1825876568 | K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY | JLW | 1992-06-18 |
| 9764 | 1231628086 | K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CGJ | 1992-06-16 |
| 9764 | 1905594449 | K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | JHI | 1992-07-28 |
| 9764 | 1499689746 | K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CEP | 1992-04-08 |
| 9764 | 1411609845 | K920661 | VIDAS CMV IGG ASSAY | LFZ | 1993-02-12 |
| 9764 | 1799160986 | K240279 | VIDAS TBI (GFAP, UCH-L1) | QAT | 2024-05-01 |
| 9764 | 1533054064 | K210793 | VIDAS NEPHROCHECK | PIG | 2022-07-08 |
| 9764 | 2034395095 | K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) | PRI | 2017-02-23 |
| 9764 | 1483748125 | K160911 | VIDAS B.R.A.H.M.S. PCT (PCT) | PMT | 2016-06-28 |
| 9764 | 1865674593 | K132010 | VIDAS C DIFFICILE GDH | MCB | 2013-10-09 |
| 9764 | 1791179839 | K122986 | VIDAS LYME IGG | LSR | 2013-03-05 |
| 9764 | 2058218061 | K122979 | VIDAS LYME IGM | LSR | 2013-06-04 |
| 9764 | 1174969039 | K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) | DAP | 2012-07-31 |
| 9764 | 1113931109 | K101946 | VIDAS TOXO IGG AVIDITY | LGD | 2011-05-18 |
| 9764 | 1978756161 | K080931 | VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY | LLH | 2008-06-11 |
| 9764 | 1849338542 | K080766 | VIDAS RUB IGG | LFX | 2008-12-23 |
| 9764 | 1335941147 | K071146 | VIDAS B.R.A.H.M.S. PCT ASSAY | NTM | 2007-10-11 |
| 9764 | 1518100598 | K001460 | VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 | LYR | 2000-10-04 |
| 9764 | 1726908995 | ||||
| 9764 | 1040212648 | ||||
| 9764 | 1108449163 | ||||
| 9764 | 1129612124 | ||||
| 9764 | 1273471707 | ||||
| 9764 | 1354570696 | ||||
| 148374 | 1419722653 | ||||
| 9764 | 1556508340 | ||||
| 9764 | 1561952198 | ||||
| 9764 | 1769950049 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LGD | 3 | 2011-05-18 |
| LSR | 2 | 2013-06-04 |
| QAT | 1 | 2024-05-01 |
| PIG | 1 | 2022-07-08 |
| PRI | 1 | 2017-02-23 |
| PMT | 1 | 2016-06-28 |
| MCB | 1 | 2013-10-09 |
| DAP | 1 | 2012-07-31 |
| LFX | 1 | 2008-12-23 |
| LLH | 1 | 2008-06-11 |
| NTM | 1 | 2007-10-11 |
| LYR | 1 | 2000-10-04 |
| GQH | 1 | 1998-12-14 |
| JLS | 1 | 1997-01-09 |
| CHP | 1 | 1996-02-06 |
| CFT | 1 | 1994-11-02 |
| LKQ | 1 | 1994-08-02 |
| LJY | 1 | 1993-08-09 |
| JFT | 1 | 1993-07-27 |
| KLI | 1 | 1993-05-13 |
| LFZ | 1 | 1993-02-12 |
| LFY | 1 | 1992-10-26 |
| JHI | 1 | 1992-07-28 |
| JLW | 1 | 1992-06-18 |
| CGJ | 1 | 1992-06-16 |
| CEP | 1 | 1992-04-08 |
PMN#
VIDAS NEPHROCHECK
BioMérieux SA
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
BioMerieux SA
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
BioMerieux SA
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
BioMerieux SA
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 Ug/mL)
BioMerieux SA
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 Ug/mL)
BioMerieux SA
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
BioMerieux SA
CHROMID CARBA Agar (CARB)
BioMerieux SA
ETEST Telavancin (TLA) (0.002-32 Ug/mL)
BioMerieux SA
RAPIDEC CARBA NP
BIOMERIEUX SA
Etest Ceftaroline (0.002 - 32ug/ml)
BIOMERIEUX SA
VIDAS FT4
BIOMERIEUX SA
VIDAS C DIFFICILE GDH
BIOMERIEUX SA
VIDAS LYME IGM
BIOMERIEUX SA
VIDAS LYME IGG
BIOMERIEUX SA
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
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.
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.
2016-08-31
VITEK®MS - DVD to install VITEK MS SW v1.0 and VITEK MS FlexPrep v1.0 for clinical customers
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.
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.
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.
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.
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)
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.
2019-11-19
ASTUTE140 Electronic Quality Control (EQC) Device - 400016
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.
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.
2016-08-12
NEPHROCHECK Liquid Control Kit - The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2020-04-10
CHROMID® P. aeruginosa Agar - Direct identification of Pseudomonas aeruginosa in pulmonary specimens.
2020-05-19
CHROMID® Candida Agar - Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans
2020-05-19
CHROMID® C. difficile - Chromogenic medium for the detection and ident ification of Clostridium difficile.
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
2022-04-05
CHROMID® P. aeruginosa Agar - Direct identification of Pseudomonas aeruginosa in pulmonary specimens.
2020-05-19
CHROMID® Candida Agar - Chromogenic medium for the selective isolation of yeasts and the direct identification of Candida albicans
2020-05-19
CHROMID® C. difficile - Chromogenic medium for the detection and ident ification of Clostridium difficile.
2020-05-19
Todd Hewitt Broth + Antibiotics - selective enrichment broth for the detection of group B streptococci in pregnant women.
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.
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.
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.
2020-04-10
API® 20 E - API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gramnegative rods
2020-04-10
CHROMID® Salmonella Elite - chromID™ Salmonella Eliteagar is a chromogenic medium for the selective isolation and identification of Salmonellain human specimens (stools)
2020-05-19
CHROMID® CPS® Elite Agar (CPSE) - Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
2020-05-19
CHROMID® CPS® Elite Agar (CPSO) - Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
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
2020-05-19
CHROMID® S. aureus Elite agar - Selective isolation and direct identification of Staphylococcus aureus
2020-05-19