inforMED
PGVClass IILife-sustaining

Anti-phospholipase A2 Receptor

Microbiology · 21 CFR 866.5780

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.

MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances2All time

Recent MDR events

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Event type breakdown

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Recalls

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