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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device human leukocyte antigen (hla) typing companion diagnostic test
Definition A Human Leukocyte Antigen (HLA) Typing Companion Diagnostic (CDx) Test is a prescription genotyping or phenotyping assay intended for use as an aid in identifying patients who have specific HLA allele(s) or express specific HLA antigen(s) and may benefit from treatment with a corresponding therapeutic product, or are likely to be at increased risk for serious adverse reactions as a result of treatment with a corresponding therapeutic product.
Product CodeQUK
Regulation Number 866.5960
Device Class 2


Premarket Reviews
ManufacturerDecision
ONE LAMBDA, INC.
  SUBSTANTIALLY EQUIVALENT 1

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