mCup® MCP7A-001
mCup MCP7A-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 10867802000228), 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 | Number10867802000228 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 10867802000228
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- Withdrawn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
- MCP7A-001
- Primary DI / UDI-DI
- 10867802000228
- FDA product code
- LFG, LDJ, LCM, JXN, JXM, DKZ, DJR, DJG, DJC, DIS, DIO
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3910, 862.3870, 862.3700, 862.3170, 862.3100, 862.3620, 862.3650, 862.3610, 862.3150, 862.3250
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.