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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transport medium, notified per the vtm guidance
Definition Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).
Product CodeQMC
Regulation Number 866.2390
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Haimen Shengbang Laboratory Equipment Co. Ltd. I Aug-08-2022
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