NVQ — Bacteriophage And Controls, B. Anthracis Lysis Class II
FDA product code NVQ covers "Bacteriophage And Controls, B. Anthracis Lysis", a Class II medical device regulated under 21 CFR 866.3045. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NVQ
- Device Class
- Class II
- Regulation Number
- 866.3045
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143592 | surgeon general, department of the army | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC | April 16, 2015 |
| K051794 | office of the surgeon general, u.s. army | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS | August 16, 2005 |