NVQ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Bacteriophage And Controls, B. Anthracis Lysis

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3045

Medical specialty

Microbiology

FDA 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.

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