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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assayed quality control material for clinical microbiology assays
Regulation Description Assayed quality control material for clinical microbiology assays.
Definition Serologic controls for microbiology assays
Product CodeQCH
Regulation Number 866.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
TECHNO-PATH MANUFACTURING , LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECHNO-PATH MANUFACTURING LTD.
  SUBSTANTIALLY EQUIVALENT 1

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