| Device |
dna-reagents, neisseria |
| Regulation Description |
Neisseriaspp. direct serological test reagents. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | LSL |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3390
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Recognized Consensus Standard
|
Guidance Document
- Draft Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia trachomatis and/or Neisseria gonorrhoea: Screening and Diagnostic Testing
|
|
| Third Party Review |
Not Third Party Eligible |
|
|
