| Device Type ID | 3325 |
| Device Name | Antigens, 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 | GTY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3325 |
| Device | Antigens, All Groups, Streptococcus Spp. |
| Product Code | GTY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Streptococcus Spp. Serological Reagents. |
| CFR Regulation Number | 866.3740 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
False Negative Result | 13 |
False Positive Result | 3 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Chemical Spillage | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Remel Inc | II | Aug-07-2015 |