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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microbial nucleic acid storage and stabilization device
Definition Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
Product CodeQBD
Regulation Number 866.2950
Device Class 2


Premarket Reviews
ManufacturerDecision
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LONGHORN VACCINES AND DIAGNOSTICS LLC
  GRANTED 1
ZYMO RESEARCH
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Krishe Inc II Apr-13-2021
2 LONGHORN VACCINES AND DIAGNOSTIC II Sep-12-2020
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