Csi Csi-Cup-8105
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850798007664 | Date23 Jan 2019 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Csi
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Reference
- CSI-CUP-8105
- Description
- CSI Cup - CLIA Screen In-Vitro 10 Panel Drug Test, Click Seal Cap, AMP, BUP, BZO, COC, MET, MDMA, MOP, MTD, OXY, THC, 25/BX
- Primary DI / UDI-DI
- 00850798007664
- FDA Product Code
- LDJ, DJR, LAF, DIO, JXM, DJG, DKZ
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device Class
- Class II
- Regulation Number
- 862.3870, 862.3620, 862.3610, 862.3250, 862.3170, 862.3650, 862.3100
- GUDID distribution status
- In Commercial Distribution
Other devices from Transmed, Inc.
Properties
Other properties (9)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No