| Device |
enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific |
| Regulation Description |
Herpes simplex virus serological assays. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | LGC |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3305
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Guidance Document
- Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
