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Sign in to claim this brandKEY SCIENTIFIC INC
US
Last updated May 24, 2026
What KEY SCIENTIFIC INC makes
Key Scientific Inc manufactures blood refrigeration and storage systems, including dedicated blood bank refrigerators designed for clinical and laboratory use. Their portfolio also includes ultralow-temperature laboratory freezers, such as high-performance plasma freezers and ultra-low-temperature units, which preserve biological samples at subzero temperatures.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device compliance standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Key Scientific Inc manufacture?
Key Scientific Inc specializes in devices for blood storage and preservation, primarily manufacturing blood refrigerators designed for clinical and laboratory use. Their portfolio also includes ultralow-temperature laboratory freezers, such as high-performance plasma freezers and ultra-low-temperature units, which are used to maintain biological samples at subzero temperatures for long-term storage.
Where is Key Scientific Inc based?
Key Scientific Inc is based in the United States. The company operates from there while adhering to applicable U.S. medical device compliance standards, ensuring their products meet regulatory requirements for the market.
Which regulatory registries list Key Scientific Inc’s devices?
Key Scientific Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, including blood refrigerators and ultralow-temperature freezers, ensuring transparency in the medical device supply chain.
How are Key Scientific Inc’s devices classified under FDA regulations?
Key Scientific Inc’s devices, such as blood refrigerators and ultralow-temperature freezers, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- thermofisher.com
- —
- —
- [email protected]
- Phone
- 828-658-4400
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 938286804
Catalogue (259)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Thermo Scientific Forma Freezer | FDE60040LA | FDA UDI | Class II | Active |
| Thermo Scientific Revco | RDE30086LV | FDA UDI | Class II | Active |
| Thermo Scientific Jewett Blood Bank Refrigerator | REB1204V | FDA UDI | Class II | Active |
| Thermo Scientific Forma Blood Bank Refrigerator | FRBB404W | FDA UDI | Class II | Active |
| Vwr® | VWR40086LA | FDA UDI | Class II | Active |
| Thermo Scientific Forma Blood Bank Refrigerator | FRBB5004A | FDA UDI | Class II | Active |
| HERAfreeze Ultra Low Temperature Freezer | HDE40040LV | FDA UDI | Class II | Active |
| Vwr® | VWR60086LA | FDA UDI | Class II | Active |
| Thermo Scientific Revco Blood Bank Refrigerator | REB2304D | FDA UDI | Class II | Active |
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