FDA Device Entity Profile: QUALIGEN, INC.

Known Identifiers & Locations

FEI Numbers 3003355251

Owner Operator Numbers 9040045

Locations Covered CARLSBAD, CA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2032087	QUALIGEN, INC.	CARLSBAD, CA, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0022-2025	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer Reason: Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.	2024-08-26	Open, Classified	View Details

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