Devices

Device Recall FastPack Free T4 Immunoassay

Model / Serial
Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
Product Description
FastPack Free T4 Immunoassay || Chemilunescence assay for the determination of Free T4 || The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
Manufacturer
Qualigen Inc
1 Event
- Recall of Device Recall FastPack Free T4 Immunoassay

Manufacturer

Qualigen Inc

Manufacturer Address
Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
Manufacturer Parent Company (2017)
Qualigen Inc
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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