Thermo Scientific Infinity™ TR85056
Thermo Scientific Infinity™ TR85056 is a Class II device made by Fisher Diagnostics, cleared under FDA 510(k) K041657 on 30 Aug 2004 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00845275003420), 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 | Number00845275003420 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041657 | Date30 Aug 2004 | StatusActive |
Official records
- AccessGUDID record 00845275003420
- FDA 510(k) database K041657
Across registries
- FDA 510(k) K041657 decided 30 Aug 2004 Active
- FDA GUDID UDI-DI 00845275003420 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K041657
- Listed FDA GUDID 00845275003420
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thermo Scientific Infinity™
- Generic name
- Angiotensin converting enzyme (ACE) IVD, reagent
- Model / reference
- TR85056
- Primary DI / UDI-DI
- 00845275003420
- 510(k) Number
- FDA product code
- JIS
- GMDN term
- Angiotensin converting enzyme (ACE) IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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