The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantit ...



The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Components:
Recall Date:    Nov 6, 2019
Mfg:
Qualigen Inc
Mfg Country:
United States
Recall ID:    85134
Product ID:    180150
Enforcement Date:    Apr 15, 2020
Termination Date:    Sep 23, 2020
Last Published:    Sep 23, 2020

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Emert Number:    Z-1672-2020
Emert Status:    Terminated