510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PGVClass II

Anti-Phospholipase A2 Receptor

21 CFR 866.5780 / Microbiology
FDA source (opens on fda.gov)

PGV is the FDA product code for Anti-Phospholipase A2 Receptor, a class II device type, regulated under 21 CFR 866.5780. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PGV
Device name
Anti-Phospholipase A2 Receptor
FDA 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.
Regulation
21 CFR 866.5780
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PGV

By decision year
2 clearances under product code PGV with a decision year between 2014 and 2014, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PGV by decision year
YearClearances
20142

Applicants with the most clearances

Product code PGV
Applicants holding the most 510(k) clearances under product code PGV
ApplicantClearances
Euroimmun US Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code