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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antiserum, fluorescent (direct test), all groups, n. gonorrhoeae
Regulation Description Neisseria spp. direct serological test reagents.
Product CodeGTH
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1

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