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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-phospholipase a2 receptor
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.
Product CodePGV
Regulation Number 866.5780
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US
  GRANTED 1
EUROIMMUN US INC
  SUBSTANTIALLY EQUIVALENT 1

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