Product code MGV
- Device name
- Radioimmunoassay For Cyclosporine
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1235
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records
| PMA | Device | Applicant | Decision date |
|---|
| P890065S001 | 1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS | DiaSorin, Inc. | 1991-01-30 |
| P890065 | CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS | DiaSorin, Inc. | 1990-09-28 |