482 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
FDA Enforcement
Class I
·Terminated·bioMerieux, Inc.·August 29, 2018
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·March 19, 2014
NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
FDA Enforcement
Class II
·Terminated·BIOMERIEUX - Grenoble·March 4, 2020
BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·February 12, 2020
VIDAS Mumps IgG (MPG), REF 30218
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Measles IgG (MSG), REF 30219
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS FSH, REF 30407-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Estradiol II, REF 30431-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS LH, REF 30406-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS SARS-COV-2 IgM, Ref 423833-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS RUB IgG (RBG), REF 30226
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Clostridium Difficile GDH, REF 30125-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Lyme IgG II (LYM), REF 417401
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Lyme IgM II (LYM), REF 416436
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS SARS-COV-2 IgG, Ref 423834-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS PRG Progesterone, REF 30409-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022