Definition: An Invitro Diagnostic Device Used To Presumptively Detect The Presence Or Absence Of B. Anthracis Directly In Blood Specimens Or Suspicious Culture Growth.
| Device Type ID | 3608 |
| Device Name | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| 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 | NHT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3608 |
| Device | Assay, Nucleic Acid Amplification, Bacillus Anthracis |
| Product Code | NHT |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biofire Defense | III | Sep-15-2014 |