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510(k) DEN140002

EUROIMMUN ANTI-PLA2R IFA by Euroimmun US — Product Code PGV

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 29, 2014
Date Received
March 28, 2014
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Phospholipase A2 Receptor
Device Class
Class II
Regulation Number
866.5780
Review Panel
IM
Submission Type

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.

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Other clearances for product code PGV

  • K132195 — EUROIMMUN ANTI-PLA2R ELISA (IGG) (June 27, 2014)