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 W
| Device Type ID | 3611 |
| Device Name | Bacteriophage And Controls, B. Anthracis Lysis |
| Physical State | Cultured Isolates |
| Technical Method | Bacteriophage, Culture |
| Target Area | Systemic |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NVQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3611 |
| Device | Bacteriophage And Controls, B. Anthracis Lysis |
| Product Code | NVQ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |