Identity
- Trade Name
- Rap/Tac/CsA Control FDA UDI
- Generic Name
- Multiple immunosuppressant therapeutic drug monitoring IVD, control FDA UDI
- Device Name
- MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine. FDA UDI
- Model / Reference
- 290-1 FDA UDI
- Description
- MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine. FDA UDI
Identifiers
- Catalog Number
- 290-1 FDA UDI
- Primary DI / UDI-DI
- 00856743007215 FDA UDI
- 510(k) Number
- K050125 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple immunosuppressant therapeutic drug monitoring IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple immunosuppressant therapeutic drug monitoring IVD, control
Rap/Tac/CsA Control by More Diagnostics Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K050125 also covers:
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
- Rap/Tac/CsA Control — MORE DIAGNOSTICS INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- More Diagnostics Inc
Sources (1)
- FDA UDI 505a748a-4f93-4fd6-91c9-acf5e9029ed9 37 fields · synced Jun 7, 2026