Transport Medium, Notified Per The Vtm Guidance

QMC · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2390

Classification

FDA Product Code: QMC
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.2390
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 0
Registered establishments: 16

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown