bioMerieux, Inc

FDA Filings

This page includes the latest FDA filings for bioMerieux, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
BioMerieux, Inc.
VITEK 2 AST-Gram Negative Imipenem/Relebactam (=16/4 µg/mL)2020-03-13
BioMerieux, Inc.
VITEK 2 AST- Gram Negative Polymyxin B (=16 Ug/mL)2020-02-14
BioMerieux SA
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2019-11-26
BioMerieux, Inc
Vitek Densichek2019-10-31
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, Inc.
VITEK 2 AST-Gram Negative Eravacycline (=4µg/mL)2019-08-05
BioMerieux, Inc.
VITEK 2 AST-Gram Positive Dalbavancin (= 1 µg/mL)2019-06-06
BioMerieux, Inc.
BACT/ALERT MP Reagent System2019-05-15
BioMerieux SA
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 Ug/mL)2019-05-01
BioMerieux, Inc.
VITEK2 AST-Gram Negative Delafloxacin (=4 Ug/mL)2019-03-12
BioMerieux, Inc.
VITEK 2 AST-Gram Negative Minocycline (= 32 Ug/mL)2019-03-07
BioMerieux, Inc
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (=64/8 µg/mL)2019-02-26
BioMerieux, Inc.
VITEK 2 AST-Gram Negative Imipenem (= 16 Ug/mL)2019-02-20
BioMerieux, Inc.
BacT/ALERT FA Plus; BacT/ALERT PF Plus2019-02-11
BioMerieux SA
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)2019-01-11
BioMerieux, Inc.
VITEK MS2018-12-21
BioMerieux, Inc
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance2018-12-10
BioMerieux, Inc.
Bacterial Detection Systems For Platelet Transfusion Products2018-11-29
BioMerieux SA
CHROMID CARBA Agar (CARB)2018-07-06
BioMerieux SA
ETEST Telavancin (TLA) (0.002-32 Ug/mL)2018-07-03
BioMerieux, Inc.
VITEK 2 AST-YS Micafungin (8 µg/mL)2018-06-20
BioMerieux, Inc.
Bacterial Detection Systems For Platelet Transfusion Products2018-02-01
BioMerieux, Inc.
VITEK 2 AST-GN Ceftazidime/Avibactam =16 µg/mL2017-12-19
BioMerieux, Inc.
VITEK 2 AST-GN Amikacin (=64 Ug/mL)2017-12-08
BioMerieux, Inc
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 Ug/mL)2017-09-15
BioMerieux, Inc.
VITEK MS2017-07-22
BioMerieux, Inc
VITEK 2 AST-GN Ciprofloxacin (=4µg/mL)2017-06-21
BioMerieux, Inc.
Etest Ceftolozane/ Tazobactam (0.016-256 Ug/ml)2017-05-31
BIOMERIEUX SA
RAPIDEC CARBA NP2017-04-27

Latest Premarket Applications

PMAManufacturerDevice NameDate
BioMerieux, Inc.
THxID-BRAF assay kit2020-02-26
BioMerieux, Inc.
THxID BRAF assay kit2019-08-26
BioMerieux, Inc.
THxID BRAF assay kit2018-06-27
BioMerieux, Inc.
THxID-BRAF kit2016-11-22
BioMerieux, Inc.
VIDAS TOTAL PSA2016-05-31
BioMerieux, Inc.
THXID-BRAF KIT2016-04-05
BioMerieux, Inc.
VIDAS TOTAL PSA ASSAY2015-08-05
BioMerieux, Inc.
THXID BRAF KIT2015-06-05
BioMerieux, Inc.
THXID BRAF KIT2015-05-27
BioMerieux, Inc.
VIDAS TOTAL PSA2015-04-22
BioMerieux, Inc.
THXID BRAF KIT2015-04-01
BioMerieux, Inc.
THXID-BRAF KIT2015-01-30
BioMerieux, Inc.
THXID BRAF KIT2014-12-22
BioMerieux, Inc.
VIDAS TOTAL PSA (TPSA) ASSAY2014-03-06
BioMerieux, Inc.
VIDAS TOTAL PSA (TPSA) ASSAY2013-09-12
BioMerieux, Inc.
BIOMERIEUX THXID BRAF ASSAY KIT2013-05-29
BioMerieux, Inc.
VIDAS TOTAL PSA2013-03-13
BioMerieux, Inc.
VIDAS TOTAL PSA2013-03-08
BioMerieux, Inc.
VIDAS FREE PSA RT2013-01-18
BioMerieux, Inc.
VIDAS TOTAL PSA2013-01-18
BioMerieux, Inc.
VIDAS TOTAL PSA2013-01-15
BioMerieux, Inc.
VIDAS FREE PSA (FPSA) ASSAY2012-02-08
BioMerieux, Inc.
VIDAS TOTAL PSA (TPSA)2012-02-08
BioMerieux, Inc.
VIDAS FREE PSA RT ASSAY2009-10-08
BioMerieux, Inc.
VIDAS TOTAL PSA (TPSA) ASSAY2008-09-25
BioMerieux, Inc.
VIDAS TPSA ASSAY2004-07-08
BIOMERIEUX VITEK, INC.
VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL2001-10-17
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE2001-06-25
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN2001-06-13
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN2001-06-13

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
VIDAS 3
BIOMERIEUX SA2020-02-24
Etest® CEFOTAXIME
BIOMERIEUX SA2020-02-07
chromID™ MRSA /SAID
BIOMERIEUX SA2020-02-06
VIDAS®
BIOMERIEUX SA2020-02-06
VIDAS® C. difficile GDH
BIOMERIEUX SA2020-02-06
ARGENE® ADENOVIRUS R-gene KIT US
BIOMERIEUX SA2020-01-23
CHROMID® VRE Agar
BIOMERIEUX SA2020-01-14
CHROMID® MRSA agar
BIOMERIEUX SA2020-01-14
VITEK 2
BIOMERIEUX , INC.2019-12-17
VITEK Densichek
BIOMERIEUX , INC.2019-12-16
VITEK 2
BIOMERIEUX , INC.2019-12-16
Etest® QUINUPRI/DALFO
BIOMERIEUX SA2019-12-11
Etest® ERAVACYCLINE
BIOMERIEUX SA2019-11-27
VIDAS® Prolactin
BIOMERIEUX SA2019-11-27
VIDAS® QCV
BIOMERIEUX SA2019-11-27
Trypcase Soy Broth
BIOMERIEUX SA2019-11-21
VIDAS® C. difficile Toxin A & B
BIOMERIEUX SA2019-11-18
VIDAS® LH
BIOMERIEUX SA2019-11-13
Etest® IMIPENEM RELEBACTAM
BIOMERIEUX SA2019-11-06
Etest® ITRACONAZOLE
BIOMERIEUX SA2019-11-05
Etest® QUINUPRI/DALFO
BIOMERIEUX SA2019-11-05
Etest® AMPICILLIN
BIOMERIEUX SA2019-11-01
Etest® AMOXI/CLAV 2/1
BIOMERIEUX SA2019-11-01
Etest® DAPTOMYCIN
BIOMERIEUX SA2019-11-01
Etest® LINEZOLID
BIOMERIEUX SA2019-11-01
Etest® METRONIDAZOLE
BIOMERIEUX SA2019-11-01
Etest® MOXIFLOXACIN
BIOMERIEUX SA2019-11-01
Etest® LEVOFLOXACIN
BIOMERIEUX SA2019-11-01
Etest® RIFAMPICIN
BIOMERIEUX SA2019-11-01
Etest® VANCOMYCIN
BIOMERIEUX SA2019-11-01
Etest® TRIM/SULFA 1/19
BIOMERIEUX SA2019-11-01
Etest® TETRACYCLINE
BIOMERIEUX SA2019-11-01
Etest® TOBRAMYCIN
BIOMERIEUX SA2019-11-01
Etest® MINOCYCLINE
BIOMERIEUX SA2019-11-01
Etest® GENTAMICIN
BIOMERIEUX SA2019-11-01

Related Finance Registrations
bioMerieux/ADR of FRANCE0001653191
Legal Entity Identifier 549300AK8Y0LBIQ4T071 [BIOMERIEUX SA]

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