mCup® MCP5A-001
mCup MCP5A-001 is a multiple drugs of abuse IVD (FDA Class II) made by Escreen, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10867802000266), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10867802000266 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 10867802000266
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- mCup®
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / reference
- MCP5A-001
- Primary DI / UDI-DI
- 10867802000266
- FDA product code
- LDJ, LCM, LAF, DKZ, DJG, DIO
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3870, 862.3610, 862.3100, 862.3650, 862.3250
- GUDID distribution status
- In Commercial Distribution
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