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KEY 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
—
LinkedIn
—
Facebook
—
Phone
828-658-4400
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
938286804

Catalogue (259)

Page 2 of 6
DeviceModel / ReferenceRegistriesClassStatus
Thermo Scientific TDE30086LD
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE60040LV
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB2304D
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE50086LA
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB5004D
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB3004A
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB5004A
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE50040LD
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB2304W
FDA UDI
Class IIActive
Thermo Scientific TSX3004BZ
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB234D
FDA UDI
Class IIActive
Thermo Scientific Sorvall Blood Cell Washing System Centra W
FDA UDI
Class IIUnknown
Thermo Scientific HERAfreeze HDE40086LD
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB5004D
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB1204W
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BD
FDA UDI
Class IIActive
Thermo Scientific TSX1204BZ
FDA UDI
Class IIActive
Thermo Scientific Forma FDE30086LA
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB3004D
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB1204A
FDA UDI
Class IIActive
Thermo Fisher Scientific Forma Blood Bank Refrigerator FRBB2304A
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE50040LA
FDA UDI
Class IIActive
Thermo Scientific TDE60086LD
FDA UDI
Class IIActive
Thermo Scientific Forma FDE40086LV
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE60040LD
FDA UDI
Class IIActive
Thermo Scientific TDE60086MV
FDA UDI
Class IIActive
Thermo Scientific Plasma Blast Freezer XBF40D-MD
FDA UDI
Class IIActive
Thermo Scientific Revco RDE60086MV
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB5004V
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE50086LD
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE50040LV
FDA UDI
Class IIActive
Cardinal Health Plasma Freezer CH5030LD
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE60086LD
FDA UDI
Class IIActive
Thermo Scientific Forma FDE60086LV
FDA UDI
Class IIActive
Thermo Scientific TSX1204BY
FDA UDI
Class IIActive
Thermo Scientific Forma FDE40086LD
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LY
FDA UDI
Class IIActive
HERAfreeze Ultra Low Temperature Freezer HDE40040LA
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer TDE40040LA
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB2304W
FDA UDI
Class IIActive
Thermo Scientific TDE40086LV
FDA UDI
Class IIActive
Thermo Scientific TDE60086MD
FDA UDI
Class IIActive
Thermo Scientific TSX1204BA
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer TDE50040LV
FDA UDI
Class IIActive
HERAfreeze Ultra Low Temperature Freezer HDE60040LV
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB234A
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086MA
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB2304V
FDA UDI
Class IIActive

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