Thermo Scientific Infinity™ TR25421
Thermo Scientific Infinity™ TR25421 is a Class II device made by Fisher Diagnostics, cleared under FDA 510(k) K070064 on 22 May 2007 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00845275002751), 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 | Number00845275002751 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070064 | Date22 May 2007 | StatusActive |
Official records
- AccessGUDID record 00845275002751
- FDA 510(k) database K070064
Across registries
- FDA 510(k) K070064 decided 22 May 2007 Active
- FDA GUDID UDI-DI 00845275002751 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K070064
- Listed FDA GUDID 00845275002751
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thermo Scientific Infinity™
- Generic name
- Alpha-amylase isoenzyme IVD, reagent
- Model / reference
- TR25421
- Primary DI / UDI-DI
- 00845275002751
- 510(k) Number
- FDA product code
- JFJ
- GMDN term
- Alpha-amylase isoenzyme IVD, reagent
- Device class
- Class II
- Regulation number
- 862.1070
- GUDID distribution status
- In Commercial Distribution
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