Rap/Tac/CsA Control 280-3
Rap/Tac/CsA Control 280-3 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 00856743007147), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number00856743007147 | Date5 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050125 | Date18 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 00856743007147
- FDA 510(k) database K050125
Across registries
- FDA 510(k) K050125 decided 18 Mar 2005 Active
- FDA GUDID UDI-DI 00856743007147 listed 5 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K050125
- Listed FDA GUDID 00856743007147
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- Withdrawn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
- 280-3
- Primary DI / UDI-DI
- 00856743007147
- 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
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)).
- BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS by Boehringer Mannheim Corp.
- CLP COMPREHENSIVE LIPID CONTROL-HR by Creative Laboratory Products, Inc.
- URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II by Fisher Scientific Co., LLC
- MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA by Roche Diagnostics Corp.
- Multichem A1c HB001A by Techno-Path Manufacturing
- LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS by Bio-Rad
- LDL-DIRECT CONTROLS by Isolab, Inc.
- LIQUICHEK ETHANOL/AMMONIA CONTROL by Bio-Rad
- Audit MicroControls Linearity LQ Special Diabetes by Aalto Scientific, Ltd.
- ABX Pentra N MultiControl 1300054414 by Horiba Abx