| Device Type ID | 3326 |
| Device Name | Antisera, All Groups, Streptococcus Spp. |
| Regulation Description | Streptococcus Spp. Serological 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 | 866.3740 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GTZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3326 |
| Device | Antisera, All Groups, Streptococcus Spp. |
| Product Code | GTZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Streptococcus Spp. Serological Reagents. |
| CFR Regulation Number | 866.3740 [🔎] |
| Device Problems | |
|---|---|
False Negative Result | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
False Positive Result | 1 |
| Total Device Problems | 9 |