NVQ

Bacteriophage And Controls, B. Anthracis Lysis

Product code

NVQ

Device name

Bacteriophage And Controls, B. Anthracis Lysis

Device class

Class 2

21 CFR

21 CFR 866.3045

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).