510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QMCClass I

Transport Medium, Notified Per The Vtm Guidance

21 CFR 866.2390 / Microbiology
FDA source (opens on fda.gov)

QMC is the FDA product code for Transport Medium, Notified Per The Vtm Guidance, a class I device type, regulated under 21 CFR 866.2390. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 4 recalls.

Classification record

Product code
QMC
Device name
Transport Medium, Notified Per The Vtm Guidance
FDA 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).
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order