BEUDAMED
    781 results · 34ms · Sources: EU EUDAMED, US FDA

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    VARIANTNBS WITH GDM 3.1 SOFTWARE

    FDA Adverse Event
    Malfunction ·BIO-RAD LABORATORIES·Product code GKA·October 15, 2013

    VARIANT NBS SICKLE CELL PROGRAM

    FDA Adverse Event
    Malfunction ·BIO-RAD LABORATORIES INC.·Product code GKA·December 16, 2013

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code GKA·April 22, 2010

    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022

    ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.

    FDA Recall
    Terminated ·PerkinElmer LAS Inc·Product code GKA·September 14, 2004

    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

    FDA Recall
    Terminated ·Primus Corporation·Product code GKA·October 9, 2020

    Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code GKA·April 14, 2010

    Abnormal Hemoglobin Quantitation

    FDA classification
    FDA Class 2 ·Abnormal Hemoglobin Quantitation

    BK-A

    FDA UDI
    BIOTRONIK SE & Co. KG·04035479144739·

    Hercules Air Mattress Controller

    FDA UDI
    MOREL COMPANY, LLC., THE·00819552022343·Controller, Kap Medical, Revision A

    FKA Distributing Co., LLC

    FDA registration
    FKA Distributing Co., LLC·13 products·🇺🇸 United States

    FKA Distributing Co., LLC

    FDA registration
    FKA Distributing Co., LLC·20 products·🇺🇸 United States

    G.A. SURGICAL (PVT) LTD.

    FDA registration
    G.A. SURGICAL (PVT) LTD.·42 products·🇵🇰 Pakistan

    G.A. YELLOWS CO., LTD

    FDA registration
    G.A. YELLOWS CO., LTD·2 products·🇯🇵 Japan