408 results
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14ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·October 17, 2012
VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·September 27, 2017
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·May 11, 2016
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·October 8, 2025
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·September 7, 2022
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
VIDAS Mumps IgG (MPG), REF 30218
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·January 5, 2022
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
FDA Enforcement
Class II
·Ongoing·bioMerieux, Inc.·August 31, 2022
VIDAS SARS-COV-2 IgM, Ref 423833-01
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 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 Measles IgG (MSG), REF 30219
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 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 PRG Progesterone, REF 30409-01
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 Clostridium Difficile GDH, REF 30125-01
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