Rap/Tac/CsA Control 285-3
Rap/Tac/CsA Control 285-3 is a Class I device made by More Diagnostics Inc, cleared under FDA 510(k) K050125 on 18 Mar 2005 and listed in FDA GUDID since 5 Apr 2018 (UDI-DI 00856743007185), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856743007185 | Date5 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050125 | Date18 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 00856743007185
- FDA 510(k) database K050125
Across registries
- FDA 510(k) K050125 decided 18 Mar 2005 Active
- FDA GUDID UDI-DI 00856743007185 listed 5 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K050125
- Listed FDA GUDID 00856743007185
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rap/Tac/CsA Control
- Generic name
- Multiple immunosuppressant therapeutic drug monitoring IVD, control
- Model / Ref / Catalog
- 285-3
- Primary DI / UDI-DI
- 00856743007185
- 510(k) Number
- FDA product code
- JJY
- GMDN term
- Multiple immunosuppressant therapeutic drug monitoring IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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