FDA Product Code PGV: Anti-phospholipase A2 Receptor
The Test System Is Intended For The Qualitative Determination Of Igg Class Autoantibodies Against Phospholipase A2 Receptor (pla2r) In Human Serum. It Is Used As An Aid In The Diagnosis Of Primary Membranous Glomerulonephritis (pmgn), In Conjunction With Other Laboratory And Clinical Findings.
Leading manufacturers include Euroimmun US and Euroimmun Us, Inc..
2
Total
1
Cleared
205d
Avg days
2014
Since
FDA 510(k) Cleared Anti-phospholipase A2 Receptor Devices (Product Code PGV)
2 devices
Cleared
Jun 27, 2014
EUROIMMUN ANTI-PLA2R ELISA (IGG)
Euroimmun Us, Inc.
Immunology
347d
Not Cleared
May 29, 2014
EUROIMMUN ANTI-PLA2R IFA
Euroimmun US
Immunology
62d