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Genabio Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest Approval2025-09-05
TypeNumberDevice NameCodeDate
510(k) K251753 GenaCheck COVID-19 Rapid Self-Test QYT 2025-09-05 View
510(k) K240545 GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) LZA 2024-08-28 View