Product code NVQ

Device name: Bacteriophage And Controls, B. Anthracis Lysis
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.3045
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K143592	GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC	The Surgeon General, Department of the Army	2015-04-16
K051794	GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS	Office of the Surgeon General, U.S. Army	2005-08-16

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