2 results
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
FDA Enforcement
Class III
·Ongoing·Qualigen Inc·January 15, 2025
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
FDA Enforcement
Class II
·Ongoing·Qualigen Inc·October 16, 2024