Biomerieux Vitek Inc

FDA Filings

This page includes the latest FDA filings for Biomerieux Vitek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
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 QUINUPRISTIN/DALFOPRISTIN2001-06-13
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN2001-06-13
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN2001-05-30
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN2001-05-14
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE2001-03-09
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN2000-08-11
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE2000-06-26
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN2000-06-21
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE2000-06-21
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR CEFTRIAXONE2000-06-21
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR ERYTHROMYCIN2000-06-14
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN2000-06-09
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL2000-06-08
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR CEFOTAXIME2000-06-06
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CEFEPIME2000-05-18
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM2000-04-26
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID2000-04-17
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN2000-04-05
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN2000-03-31
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM2000-03-31
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID2000-03-20
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID2000-03-20
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME2000-03-20
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM2000-03-09
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN/TAZOBACTAM2000-02-17
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR OXACILLIN2000-02-15
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CEFOXITIN2000-02-10
BIOMERIEUX VITEK, INC.
VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN2000-02-08
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE TETRACYCLINE2000-02-08
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN2000-02-08
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE NORFLOXACIN2000-02-07
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME2000-02-01
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN2000-02-01
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR GENTAMICIN2000-01-31
BIOMERIEUX VITEK, INC.
VITEK(R) GRAM POSITIVE AST FOR NORFLOXACIN2000-01-31
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN2000-01-24
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN2000-01-21
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR LEVOFLOXACIN2000-01-10
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN2000-01-06
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR CIPROFLOXACIN1999-12-10
BIOMERIEUX VITEK, INC.
VITEK(R) 2 GRAM POSITIVE AST FOR ERYTHROMYCIN1999-12-10
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR PIPERACILLIN1999-12-10
BIOMERIEUX VITEK, INC.
VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM1999-12-03
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN1999-11-15
BIOMERIEUX VITEK, INC.
VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE1999-11-10
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM1999-11-10
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CEFOTETAN1999-11-08
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR LEVOFLOXACIN1999-11-05
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE1999-11-05
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN1999-10-07
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR CIPROFLOXACIN1999-09-23
BIOMERIEUX VITEK, INC.
VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN1999-09-17
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE SUSCEPTIBILITY FOR OXACILLIN1999-07-26
BIOMERIEUX VITEK, INC.
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-CEFTRIAXONE1999-07-12
BIOMERIEUX VITEK, INC.
VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM1999-07-09
BIOMERIEUX VITEK, INC.
VITEK 2 SYSTEM1999-07-09
BIOMERIEUX VITEK, INC.
VITEK 2 SYSTEM1999-06-28
BIOMERIEUX VITEK, INC.
VITEK 2 SYSTEM1999-06-24
BIOMERIEUX VITEK, INC.
VITEK 2 SYSTEM1999-06-16
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1998-09-15
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)1998-08-14
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1998-04-14
BIOMERIEUX VITEK, INC.
VIDAS D-DIMER (DD) ASSAY1998-03-10
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-12-08
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-12-08
BIOMERIEUX VITEK, INC.
VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
BIOMERIEUX VITEK, INC.
VIDAS ROTAVIRUS ASSAY1997-05-05
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-04-24
BIOMERIEUX VITEK, INC.
VIDAS C. DIFFICILE TOXIN A II ASSAY1997-04-08
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-03-27
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-03-17
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-02-19
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1997-02-19
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1996-12-20
BIOMERIEUX VITEK, INC.
VIDAS CHLAMYDIA BLOCKING ASSAY1996-10-07
BIOMERIEUX VITEK, INC.
GRAM NEGATIVE IDENTIFICATION PLUS CARD1996-08-30
BIOMERIEUX VITEK, INC.
VIDAS CREATINE KINASE MB ASSAY 30-4211996-08-30
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1996-08-07
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1996-04-22
BIOMERIEUX VITEK, INC.
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)1996-03-12
BIOMERIEUX VITEK, INC.
VIDAS ESTRADIOL II (E2II) ASSAY1996-02-06
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1996-01-17
BIOMERIEUX VITEK, INC.
VITEK LOMEFLOXACIN1995-11-16
BIOMERIEUX VITEK, INC.
VIDAS LYME SCREEN II1995-06-13
BIOMERIEUX VITEK, INC.
HEMOLAB COFAC IX1995-05-19
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB COFAC II1995-05-19
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1995-04-19
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1995-03-01
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1995-02-23
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB COFAC X1995-01-17
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB COFAC VII1995-01-17
BIOMERIEUX VITEK, INC.
HEMOLAB PROTEIN C CHROMOGENIC ASSAY1994-12-22
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB AT III1994-12-22
BIOMERIEUX VITEK, INC.
HEMOLAB1994-12-22
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1994-12-14
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1994-11-03
BIOMERIEUX VITEK, INC.
ENZYME-LINKED FLUORESCENT IMMUNOASSAY1994-11-02
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1994-08-30
BIOMERIEUX VITEK, INC.
VIDAS CMV IGM ASSAY1994-08-02
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1994-06-17
BIOMERIEUX VITEK, INC.
HEMOLAB HEPARICHROM ASSAY1994-05-06
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB THROMBICALCI-TEST1994-04-21
BIOMERIEUX VITEK, INC.
VIDAS T UPTAKE1994-03-22
BIOMERIEUX VITEK, INC.
VIDAS T3 ASSAY1994-03-22
BIOMERIEUX VITEK, INC.
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL1994-03-22
BIOMERIEUX VITEK, INC.
FDP - SLIDEX DIRECT1993-11-03
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB COFAC VIII1993-09-15
BIOMERIEUX VITEK, INC.
VIDAS DIGOXIN (DIG)1993-09-10
BIOMERIEUX VITEK, INC.
VIDAS THEOPHYLLINE(THEO)1993-08-16
BIOMERIEUX VITEK, INC.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA1993-08-09
BIOMERIEUX VITEK, INC.
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT1993-07-27
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1993-06-24
BIOMERIEUX VITEK, INC.
VIDAS TOXO COMPETITION (TXC) ASSAY1993-06-21
BIOMERIEUX VITEK, INC.
VIDAS TOTAL IGE (IGE) ASSAY1993-05-20
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB FIBRINOMAT1993-05-18
BIOMERIEUX VITEK, INC.
VIDAS THYROXINE (T4) ASSAY (T4)1993-05-13
BIOMERIEUX VITEK, INC.
VIDAS TOXO IG6 ASSAY (TX6)1993-05-11
BIOMERIEUX VITEK, INC.
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD1993-03-23
BIOMERIEUX VITEK, INC.
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD1993-03-23
BIOMERIEUX VITEK, INC.
VIDAS TOXOPLASMA GONDII IGM ASSSAY1993-02-25
BIOMERIEUX VITEK, INC.
VIDAS ESTRADIOL (E2) ASSAY1993-02-12
BIOMERIEUX VITEK, INC.
MINIVIDAS INSTRUMENT1993-02-12
BIOMERIEUX VITEK, INC.
BIOMERIEUX HEMOLAB THROMBOMAT1993-02-03
BIOMERIEUX VITEK, INC.
BAC-T-SCREEN1993-02-03
BIOMERIEUX VITEK, INC.
VIDAS FREE THYROXINE(FT4) ASSAY1992-11-30
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1992-11-19
BIOMERIEUX VITEK, INC.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-10-26
BIOMERIEUX VITEK, INC.
RAPID NFT, MODIFICATION1992-10-14
BIOMERIEUX VITEK, INC.
SLIDEX STAPH-KIT1992-09-28
BIOMERIEUX VITEK, INC.
HEMOLAB SILIMAT REAGENT1992-09-25
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1992-06-22
BIOMERIEUX VITEK, INC.
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY1992-06-18
BIOMERIEUX VITEK, INC.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-06-16
BIOMERIEUX VITEK, INC.
VITEK IMIPENUM CARD1990-10-22
BIOMERIEUX VITEK, INC.
VITEK(R) AMPICILLIN/SULBACTAM1990-10-04
BIOMERIEUX VITEK, INC.
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD1990-09-24
BIOMERIEUX VITEK, INC.
VITEK MINOCYCLINE CARD1990-08-03
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1990-03-08
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1989-04-12
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-12-22
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-11-01
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-10-24
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-09-26
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-09-07
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-08-22
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-08-10
BIOMERIEUX VITEK, INC.
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS1988-01-13

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