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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 5 of 6
DeviceModel / ReferenceRegistriesClassStatus
Cardinal Health Blood Bank Refrigerator CH2304BD
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE50086LA
FDA UDI
Class IIActive
Thermo Scientific TDE50086LD
FDA UDI
Class IIActive
Thermo Scientific TDE60086MA
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB3004A
FDA UDI
Class IIActive
Vwr® VWR50086LD
FDA UDI
Class IIActive
Vwr® VWR60086LD
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB5004W
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE60040LD
FDA UDI
Class IIActive
Thermo Scientific Revco RDE60086LA
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LY
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086LA
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LZ
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB5004A
FDA UDI
Class IIActive
Thermo Scientific TDE40086LD
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE30086LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BD
FDA UDI
Class IIActive
HERAfreeze Ultra Low Temperature Freezer HDE40040LD
FDA UDI
Class IIActive
Vwr® VWR30086LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LZ
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator CH2304BA
FDA UDI
Class IIActive
Thermo Scientific TDE60086LV
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE50040LV
FDA UDI
Class IIActive
Thermo Scientific Revco RDE60086MD
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE60086LA
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB46A
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB404A
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE40086LD
FDA UDI
Class IIActive
Cardinal Health Plasma Freezer CH5030LA
FDA UDI
Class IIActive
Thermo Scientific Forma FDE30086LV
FDA UDI
Class IIActive
Thermo Scientific TSX2304BY
FDA UDI
Class IIActive
Thermo Scientific TSX3004BV
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE40040LV
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB1204V
FDA UDI
Class IIActive
Thermo Scientific Forma Blood Bank Refrigerator FRBB1204V
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE40040LD
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE60040LV
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB2304A
FDA UDI
Class IIActive
Thermo Scientific TDE40086LA
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB5004W
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LA
FDA UDI
Class IIActive
Thermo Scientific Revco RDE60086MA
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigeratr REB2304V
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BV
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LV
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE50040LA
FDA UDI
Class IIActive
Thermo Scientific Forma FDE30086LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX2304BV
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086LV
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE30086LV
FDA UDI
Class IIActive

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