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    VITEK2 GP-ID, REF 21342 IVD

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·November 15, 2017

    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

    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    FDA Enforcement
    Class II ·Terminated·Randox Laboratories Ltd.·January 2, 2019

    Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m) AST-GN69, REF 413400, n) AST-GN73, REF 413404, o) AST-GN79, REF 413436, p) AST-GN82, REF 413439, q) AST-N261, REF 413753, r) AST-XN06, REF 413944, s) AST-N275, REF 414313, t) AST-GP75, REF 415670, u) AST-N300, REF 416241, v) AST-N308, REF 413913, w) AST-N314, REF 417027, x) AST-N318, REF 417952, y) AST-P643, REF 418671, z) AST-YS08, REF 420739, aa) AST-N348, REF 420856, bb) AST-ST02, REF 420915, cc) AST-ST03, REF 421040, dd) AST-N355, REF 421351, ee) AST-P654, REF 421912, ff) AST-P655, REF 421913, gg) AST-N371, REF 422024, hh) AST-N372, REF 422241, ii) AST-N379, REF 423052,

    FDA Enforcement
    Class II ·Terminated·Organon Teknika Inc·March 6, 2019

    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022