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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 3 of 6
DeviceModel / ReferenceRegistriesClassStatus
Thermo Scientific TSX5004BZ
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE30086LD
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE60086LV
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB1204A
FDA UDI
Class IIUnknown
Thermo Scientific Forma FDE50086LA
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086MD
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB404D
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator BBR25D-1B
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE60086MV
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX2330LZ
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer TDE40040LV
FDA UDI
Class IIActive
Thermo Scientific Revco RDE50086LA
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LV
FDA UDI
Class IIActive
Thermo Scientific Forma FDE40086LA
FDA UDI
Class IIActive
Thermo Scientific HERAfreeze HDE40086LV
FDA UDI
Class IIActive
Thermo Scientific Revco RDE50086LD
FDA UDI
Class IIActive
Thermo Scientific Sorvall Blood Washing System CW2 Plus
FDA UDI
Class IIUnknown
Thermo Scientific Jewett Blood Bank Refrigerator JBB5004V
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB3004V
FDA UDI
Class IIActive
Thermo Scientific TDE60086LA
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX3030LV
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator JBB2304W
FDA UDI
Class IIActive
Thermo Scientific Forma Freezer FDE40040LA
FDA UDI
Class IIActive
Thermo Scientific Forma FDE60086LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Blood Bank Refrigerator TSX5004BA
FDA UDI
Class IIActive
Thermo Scientific TSX Universal Series ULT Freezer TSX40086LA
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE40040LA
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX1230LA
FDA UDI
Class IIActive
Thermo Scientific Revco RDE40086LA
FDA UDI
Class IIActive
Thermo Scientific Jewett Blood Bank Refrigerator BBR55D-2A
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB304D
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE40040LD
FDA UDI
Class IIActive
Thermo Scientific Revco RDE40086LV
FDA UDI
Class IIActive
Cardinal Health Plasma Freezer CH1230LD
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer RDE30086LA
FDA UDI
Class IIActive
Thermo Scientific Revco Freezer TDE50040LD
FDA UDI
Class IIActive
Thermo Scientific TSX Series High-Performance Plasma Freezer TSX5030LA
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB124D
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB5004W
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB404D
FDA UDI
Class IIUnknown
Cardinal Health Blood Bank Refrigerator CH1204BA
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB3004W
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB504D
FDA UDI
Class IIActive
Thermo Scientific Forma FDE50086LV
FDA UDI
Class IIActive
Cardinal Health Blood Bank Refrigerator BB124A
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB5004V
FDA UDI
Class IIActive
Thermo Scientific Forma FDE60086LA
FDA UDI
Class IIActive
Thermo Scientific Revco Blood Bank Refrigerator REB404A
FDA UDI
Class IIActive
Vwr® VWR50086LA
FDA UDI
Class IIActive
Fisherbrand™ Isotemp™ Ultra-Low-Temperature Freezer IUE40086LA
FDA UDI
Class IIActive

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