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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alpha-1-antitrypsin kit, qualitative phenotype
Regulation Description Alpha-1-antitrypsin immunological test system.
Definition The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.
Product CodeOBZ
Regulation Number 866.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
HELENA LABORATORIES, CORP.
  SUBSTANTIALLY EQUIVALENT 1

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