BEUDAMED
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    Filters Classification: Class Iii × Regulation: Us FDA × Clear all

    Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

    FDA Enforcement
    Class III ·Terminated·Randox Laboratories Ltd.·February 12, 2020

    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

    FDA Enforcement
    Class III ·Terminated·Beckman Coulter Inc.·August 29, 2012

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017