Rapid Response D4.57-1VF
by BTNX Inc
Rapid Response D4.57-1VF is a Class II device made by BTNX Inc, cleared under FDA 510(k) K180349 on 5 Apr 2018 and listed in FDA GUDID since 1 Apr 2024 (UDI-DI 10722066008123), 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 | Number10722066008123 | Date1 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180349 | Date5 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 10722066008123
- FDA 510(k) database K180349
Across registries
- FDA 510(k) K180349 decided 5 Apr 2018 Active
- FDA GUDID UDI-DI 10722066008123 listed 1 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K180349
- Listed FDA GUDID 10722066008123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rapid Response
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / reference
- D4.57-1VF
- Primary DI / UDI-DI
- 10722066008123
- 510(k) Number
- FDA product code
- NGL, NFT, NGG, NFY
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3650, 862.3100, 862.3610, 862.3250
- GUDID distribution status
- In Commercial Distribution
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