BEUDAMED
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    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454809·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454823·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454854·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454830·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454847·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454861·Latex male condom for contraception and prevent...

    Caliber

    FDA UDI
    Caliber Brand LLC·00860011454816·Latex male condom for contraception and prevent...

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LCP·December 1, 2009