System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

POC · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1640

Classification

FDA Product Code: POC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.1640
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 4

Source

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