Isotemp™ IUEC25286LA
by Thermo Fisher Scientific (Asheville) LLC
Isotemp™ IUEC25286LA is a Class II device made by Thermo Fisher Scientific (Asheville) LLC, listed in FDA GUDID since 1 Dec 2022 (UDI-DI 00815773020557), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00815773020557 | Date1 Dec 2022 | StatusListed |
Official records
- AccessGUDID record 00815773020557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Isotemp™
- Generic name
- Ultralow-temperature laboratory freezer
- Model / Ref / Catalog
- IUEC25286LA
- Primary DI / UDI-DI
- 00815773020557
- FDA product code
- KSE
- GMDN term
- Ultralow-temperature laboratory freezer
- Device class
- Class II
- Regulation number
- 864.9700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices
Other devices filed under FDA product code KSE (Refrigerator, Freezer, Blood Storage).
- Horizon Series™ HPR120-GX by HELMER Inc.
- Horizon Series™ HPR256-GX by HELMER Inc.
- SEPCOR TEMPERATURE MONITOR by Separation Science Corp.
- Haier HXC-629R by Qingdao Haier Biomedical Co Ltd
- HEMOTEMP TM by Marion Laboratories, Inc.
- Haier HXC-429R by Qingdao Haier Biomedical Co Ltd
- MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 by Harris Mfg. Co.
- MONITEMP BLOOD PACK TEMP. MONITOR by Liquid Crystal Products, Inc.
Other devices from Thermo Fisher Scientific (Asheville) LLC
See all devices from Thermo Fisher Scientific (Asheville) LLC →