Anti-Phospholipase A2 Receptor

PGV · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.5780

Classification

FDA Product Code: PGV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5780
Review panel: IM
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown