PGV · Class II · 21 CFR 866.5780

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.

2
Total
1
Cleared
205d
Avg days
2014
Since

FDA 510(k) Cleared Anti-phospholipase A2 Receptor Devices (Product Code PGV)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code PGV - Regulatory Context