| Device Type ID | 3448 |
| Device Name | Epstein-barr Virus, Other |
| Regulation Description | Epstein-Barr 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) |
| CFR Regulation Number | 866.3235 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LSE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3448 |
| Device | Epstein-barr Virus, Other |
| Product Code | LSE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Epstein-Barr Virus Serological Reagents. |
| CFR Regulation Number | 866.3235 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Use Of Incorrect Control Settings | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Diamedix Corporation | II | May-16-2016 |