Bacteriophage And Controls, B. Anthracis Lysis
The Bacteriophage and Controls for Bacillus anthracis Lysis is a gamma phage lysis assay intended to identify B. anthracis from non-hemolytic, aerobic gram-positive colonies isolated from sheep blood agar, aiding in the laboratory identification of B. anthracis culture growth through specific bacteriophage lysis. This microbiological diagnostic method exploits the high specificity of gamma phage for anthrax bacilli. It is an FDA Class 2 device regulated under 21 CFR 866.3045 in the Microbiology specialty, with product code NVQ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NVQ
- Device Class
- FDA class 2
- Regulation Number
- 866.3045
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K143592 | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC | Apr 16, 2015 | Substantially Equivalent | The Surgeon General, Department of the Army |
| K051794 | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS | Aug 16, 2005 | Substantially Equivalent | Office of the Surgeon General, U.S. Army |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.