Oichid midstream
by Weihai Kangzhou Biotechnology Engineering Co., Ltd
Oichid midstream is a Class II device made by Weihai Kangzhou Biotechnology Engineering Co., Ltd, cleared under FDA 510(k) K183097 on 10 Jan 2019 and listed in FDA GUDID since 1 Feb 2024 (UDI-DI 06923304600070), 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 | Number06923304600070 | Date1 Feb 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183097 | Date10 Jan 2019 | StatusActive |
Official records
- AccessGUDID record 06923304600070
- FDA 510(k) database K183097
Across registries
- FDA 510(k) K183097 decided 10 Jan 2019 Active
- FDA GUDID UDI-DI 06923304600070 listed 1 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K183097
- Listed FDA GUDID 06923304600070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Oichid
- Generic name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
- Model / reference
- midstream
- Primary DI / UDI-DI
- 06923304600070
- 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
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