| Device Type ID | 3248 |
| Device Name | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Regulation Description | Respiratory Syncytial Virus 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 | 866.3480 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GQG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3248 |
| Device | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Product Code | GQG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Respiratory Syncytial Virus Serological Reagents. |
| CFR Regulation Number | 866.3480 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |