Devices

FastPack Total Testosterone Immunoassay

Model / Serial
Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Switzerland.
Product Description
Device to determine quantitative total testosterone in human serum
Manufacturer
Qualigen Inc
1 Event
- Recall of FastPack Total Testosterone Immunoassay

Manufacturer

Qualigen Inc

Manufacturer Address
Qualigen Inc, 2042 Corte Del Nogal, Carlsbad CA 92009-1438
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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