Product code PGV

Device name

Anti-Phospholipase A2 Receptor

Medical specialty

Microbiology

Device class

2

Regulation number

866.5780

Review panel

IM

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

Definition

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.

Source

FDA openFDA device classification dataset