NVQClass II
Bacteriophage And Controls, B. Anthracis Lysis
21 CFR 866.3045 / Microbiology
NVQ is the FDA product code for Bacteriophage And Controls, B. Anthracis Lysis, a class II device type, regulated under 21 CFR 866.3045. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- NVQ
- Device name
- Bacteriophage And Controls, B. Anthracis Lysis
- FDA 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.
- Regulation
- 21 CFR 866.3045
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 1
Clearances, product code NVQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code NVQ| Applicant | Clearances |
|---|---|
| Office of the Surgeon General, U.S. Army | 1 |
| The Surgeon General, Department of the Army | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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