| Device |
enzyme linked immunoabsorbent assay, antibody, b. anthracis |
| Definition |
The elisa assay for antibodies to b.Anthracis is used to detect an immunological response to proteins secreted by b.Anthracis; as an aid in the laboratory diagnosis of anthrax. |
| Review Panel |
Microbiology |
|---|
| Product Code | NRL |
|---|
|
Unclassified Reason
|
Pre-Amendment
|
|---|
| Submission Type |
510(k)
|
|---|
| Device Class |
Unclassified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
