Clarisse Midstream
Clarisse Midstream is a total human chorionic gonadotropin IVD (FDA Class II; FDA product code LCX, Kit, Test, Pregnancy, Hcg, Over The Counter) made by Delta Brands Inc., cleared under FDA 510(k) K183097 on 10 Jan 2019 and listed in FDA GUDID since 25 Mar 2022 (UDI-DI 00808829120615), active 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 | Number00808829120615 | Date25 Mar 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183097 | Date10 Jan 2019 | StatusActive |
Official records
- AccessGUDID record 00808829120615
- FDA 510(k) database K183097
Across registries
- FDA 510(k) K183097 decided 10 Jan 2019 Active
- FDA GUDID UDI-DI 00808829120615 listed 25 Mar 2022 Listed
Timeline
- Cleared FDA 510(k) K183097
- Listed FDA GUDID 00808829120615
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Clarisse
- Generic name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Model / reference
- Midstream
- Description
- Over-the-counter, One Step human Chorionic Gonadotropin hCG. Colloidal Gold Urine Pregnancy. for in vitri diagnostic use only IVD. Test kit , midstream
- Primary DI / UDI-DI
- 00808829120615
- 510(k) Number
- FDA product code
- LCX
- GMDN term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.1155
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical.