BEUDAMED
    198 results · 50ms · Sources: EU EUDAMED, US FDA

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    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Enforcement
    Class II ·Ongoing·Stanbio Laboratory, LP·December 13, 2023

    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·March 21, 2018

    Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

    FDA Enforcement
    Class III ·Terminated·Stanbio Laboratory, LP·August 11, 2021

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

    Separation Technology Creamatocrit Plus, Catalog Number: 100-146

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·April 20, 2022

    QuPID® hCG

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498122020·For the qualitative determination of human chor...

    ISE Potassium Electrode

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001905·Ion-Selective Electrode for the measurement of ...

    Glucose Liqui-UV®

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000809·For the Quantitative Determination of Glucose i...

    Micro Protein (CSF/Urine) LiquiColor®

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001004·For the Quantitative Colorimetric Determination...

    Uri-Chek 10SG Strips

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000052·The Stanbio Uri-Chek™ 10SG Urinalysis Reagent S...

    CK-MB Test

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000748·For the Quantitative Determination of Creatine ...

    Sirrus® Direct LDL Cholesterol LiquiColor®

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001578·For the qualitative determination of LDL Choles...

    Sirrus® Creatinine LiquiColor®

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001554·For the Quantitative Determination of Creatinin...

    Direct Glycohemoglobin (HbA1c) Control Set

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000892·For use as controls in the Quantitative Determi...

    Reference Solution

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498001783·To provide constant electrical potential throug...

    Potassium Test

    FDA UDI
    STANBIO LABORATORY, L.P.·00657498000984·Quantitative Turbidimetric Determination of Pot...