Microbial Nucleic Acid Storage And Stabilization Device

QBD · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2950

Classification

FDA Product Code: QBD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.2950
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 17
Registered establishments: 25

Source

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