Devices

Device Recall FastPack Vitamin D Immunoassay

Model / Serial
Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
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 || FastPack Vitamin D Immunoassay || Chemilunescence assay for the determination of Vitamin D || The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.
Manufacturer
Qualigen Inc
1 Event
- Recall of Device Recall FastPack Vitamin D 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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