IH
IH-Centrifuge L - 009301
Device Description
An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.
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: 07611969226320
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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