Rapid TOX 10-10BPXT-030
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10694644100010 | Date23 Sep 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Rapid TOX
- Generic name
- Multiple therapeutic drugs/drugs of abuse IVD, calibrator
- Model / Ref / Catalog
- 10-10BPXT-030
- Primary DI / UDI-DI
- 10694644100010
- FDA product code
- DKG, DIS, JXM, DIO, DJC, DJR, DJG, JXN, LDJ, LFG, LCM
- GMDN term
- Multiple therapeutic drugs/drugs of abuse IVD, calibrator
- Device class
- Class I
- Regulation number
- 862.2270, 862.3150, 862.3170, 862.3250, 862.3610, 862.3620, 862.3650, 862.3700, 862.3870, 862.3910
- GUDID distribution status
- In Commercial Distribution
Other devices from American Bio Medica Corp.
Properties
Other properties (11)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No