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Qualigen Inc

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quant recall (Z-0805-2025)Qualigen Inc2025-01-03
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TS recall (Z-0022-2025)Qualigen Inc2024-10-08
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. F recall (Z-0547-2014)Qualigen Inc2013-12-19
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testoster recall (Z-0548-2014)Qualigen Inc2013-12-19
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The Fa recall (Z-0549-2014)Qualigen Inc2013-12-19
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the recall (Z-0550-2014)Qualigen Inc2013-12-19
FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoas recall (Z-0500-2009)Qualigen Inc2008-12-22
Device to determine quantitative total testosterone in human serum recall (Z-0090-04)Qualigen Inc2003-11-06

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Every clearance here is in the API, with alerts when new ones post.