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 IdentifiersDevice 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