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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230
Definition The device is intended as an aid in the diagnosis of bullous pemphigoid.
Product CodeOEG
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1

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