Bacteriophage And Controls, B. Anthracis Lysis

NVQ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3045

Classification

FDA Product Code: NVQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3045
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

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