Quantra QPlus System KT-0034
Quantra QPlus System KT-0034 is a Class II device made by Hemosonics LLC, granted FDA De Novo DEN180017 on 12 Mar 2019 and listed in FDA GUDID since 24 Apr 2019 (UDI-DI 10850003761081), active (FDA De Novo), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10850003761081 | Date24 Apr 2019 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN180017 | Date12 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 10850003761081
- FDA De Novo database DEN180017
Across registries
- FDA De Novo DEN180017 decided 12 Mar 2019 Active
- FDA GUDID UDI-DI 10850003761081 listed 24 Apr 2019 Listed
Timeline
- Granted FDA De Novo DEN180017
- Listed FDA GUDID 10850003761081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- Quantra QPlus System
- Generic name
- Coagulation analyser IVD, point-of-care, line-powered
- Model / reference
- KT-0034
- Primary DI / UDI-DI
- 10850003761081
- De Novo Number
- FDA product code
- QFR
- GMDN term
- Coagulation analyser IVD, point-of-care, line-powered
- Device class
- Class II
- Regulation number
- 864.5430
- GUDID distribution status
- Not in Commercial Distribution