- Physicians Office Resource

IH-Incubator L - 009303

Device Description

An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PBC

Device Name: Manual Blood Grouping And Antibody Test Systems

Device Class: 2

Physical State: Solid

Definition: A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Manual

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: IVD

Regulation Number: 864.9175

Third Party Flag: N

Medical Specialty: HE

Device Identifiers

Device Id: 07611969226344

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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