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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
AARDVARK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FERTIPRO NV
  SUBSTANTIALLY EQUIVALENT 1
LONGHORN VACCINES AND DIAGNOSTICS LLC
  GRANTED 1
MAGBIO GENOMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAWI DNA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DASKY LIFE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GENE SCIENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZYMO RESEARCH
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 BASE 10 GENETICS INC I Feb-17-2022
2 DEWEI MEDICAL EQUIPMENT CO LTD I Dec-07-2022
3 Krishe Inc II Apr-13-2021
4 LONGHORN VACCINES AND DIAGNOSTIC II Sep-12-2020
5 Mercedes Medical, Inc. II Jul-12-2021
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