Devices

Device Recall FastPack Total PSA Immunoassay

Model / Serial
Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
Product Classification
Immunology and Microbiology 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 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. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
Manufacturer
Qualigen Inc
1 Event
- Recall of Device Recall FastPack Total PSA 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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