System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

MWA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3372

Classification

FDA Product Code: MWA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3372
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

intended to detect Mycobacterium tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 4

Source

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