BluRapids™ TNR MMC12MOP
BluRapids™ TNR MMC12MOP is a Class II device made by Mercedes Medical LLC, cleared under FDA 510(k) K153050 on 26 Apr 2016 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI 00850011007099), 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 | Number00850011007099 | Date15 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153050 | Date26 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00850011007099
- FDA 510(k) database K153050
Across registries
- FDA 510(k) K153050 decided 26 Apr 2016 Active
- FDA GUDID UDI-DI 00850011007099 listed 15 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K153050
- Listed FDA GUDID 00850011007099
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BluRapids™
- Generic name
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- TNR MMC12MOP
- Primary DI / UDI-DI
- 00850011007099
- 510(k) Number
- FDA product code
- LFG, LCM, DJR, DNK, DJC, DIO, JXM, DJG, DIS, DKZ
- GMDN term
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3910, 862.3620, 862.3640, 862.3610, 862.3250, 862.3170, 862.3650, 862.3150, 862.3100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Buprenorphine IVD, kit, enzyme immunoassay (EIA).