Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

QAA · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3376

Classification

FDA Product Code: QAA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3376
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A Coccidioides spp. nucleic acid detection system for respiratory specimens is a qualitative test for the detection of Coccidioides spp. nucleic acids directly in clinical respiratory specimens from patients with signs and symptoms of coccidioidomycosis and suspicion of infection.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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