| Device Type ID | 3322 |
| Device Name | Antistreptolysin - Titer/streptolysin O Reagent |
| Regulation Description | Streptococcus Spp. Exoenzyme Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.3720 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GTQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3322 |
| Device | Antistreptolysin - Titer/streptolysin O Reagent |
| Product Code | GTQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Streptococcus Spp. Exoenzyme Reagents. |
| CFR Regulation Number | 866.3720 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2 |
Pump | 1 |
High Test Results | 1 |
| Total Device Problems | 4 |