Rapid Response COT-2FC141
by BTNX Inc
Rapid Response COT-2FC141 is a Class I device made by BTNX Inc, cleared under FDA 510(k) K223162 on 17 Mar 2023 and listed in FDA GUDID since 14 Aug 2024 (UDI-DI 10722066008376), active as of 23 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 | Number10722066008376 | Date14 Aug 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223162 | Date17 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 10722066008376
- FDA 510(k) database K223162
Across registries
- FDA 510(k) K223162 decided 17 Mar 2023 Active
- FDA GUDID UDI-DI 10722066008376 listed 14 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K223162
- Listed FDA GUDID 10722066008376
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Cotinine IVD, kit, rapid ICT, clinical
- Model / reference
- COT-2FC141
- Primary DI / UDI-DI
- 10722066008376
- 510(k) Number
- FDA product code
- MKU
- GMDN term
- Cotinine IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 862.3220
- GUDID distribution status
- In Commercial Distribution
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