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Bacteriophage And Controls, B. Anthracis Lysis

FDA product code NVQ · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3045
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-08-16 – 2005-08-16

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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