Statcup® Scp-2167-0-A
Statcup® Scp-2167-0-A is a Class II device made by Micro Distributing, L.c, cleared under FDA 510(k) K133968 on 25 Feb 2014 and listed in FDA GUDID since 2 Jul 2019 (UDI-DI 00816036026545), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816036026545 | Date2 Jul 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133968 | Date25 Feb 2014 | StatusActive |
Official records
- AccessGUDID record 00816036026545
- FDA 510(k) database K133968
Across registries
- FDA 510(k) K133968 decided 25 Feb 2014 Active
- FDA GUDID UDI-DI 00816036026545 listed 2 Jul 2019 Listed
Recalls
-
- Ongoing Z-1589-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Timeline
- Cleared FDA 510(k) K133968
- Listed FDA GUDID 00816036026545
- Recall initiated FDA recalls Z-1589-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Statcup®
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- SCP-2167-0-A
- Description
- STATCUP 6 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/OPI/THC + CR,OX,pH , 25Pcs/Box
- Primary DI / UDI-DI
- 00816036026545
- 510(k) Number
- FDA product code
- DKZ, JXM, LAF, LDJ, DJG, DIO
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3100, 862.3170, 862.3610, 862.3870, 862.3650, 862.3250
- GUDID distribution status
- In Commercial Distribution