Rapid Response D12.49-1VA
by BTNX Inc GUDID
Listed (no authorization)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10722066009083 | Date3 Oct 2025 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — GUDID listing Listed
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Rapid Response
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Reference
- D12.49-1VA
- Description
- D12.49-1VA Internal code: D12.49-1VA OXY100 BZO300 MOR300 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 FYL1+ OXI/CRE/PH
- Primary DI / UDI-DI
- 10722066009083
- FDA Product Code
- NFV, NFW, NFY, NGG, NGL, NGM, PTG, PTH, QAW
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device Class
- Class II
- Regulation Number
- 862.3170, 862.3870, 862.3250, 862.3610, 862.3650, 862.3620, 862.3150, 862.3910
- Commercial Distribution
- In Commercial Distribution
Other devices from BTNX Inc
Properties
Other properties (9)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No