BEUDAMED
    5 results · 36ms · Sources: EU EUDAMED, US FDA

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    Alpha-amylase

    Device
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·On the market·32 countries

    AMYLASE (ETHYLIDENE PNGPG7) KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Alpha-amylase

    Basic UDI-DI
    EU IVDR · Eu Ivd Class B ·Beckman Coulter Ireland Inc.·1 device

    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074

    FDA Enforcement
    Class II ·Ongoing·Randox Laboratories Ltd.·August 30, 2023