A combination centrifuge and reader for IH gel cards
IH-Reader 24 - 001200
Device Description
A mains electricity (AC-powered) laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening, antibody identification, direct antiglobulin tests and/or crossmatching of clinical specimens. It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
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: KSZ
Device Name: System, Test, Automated Blood Grouping And Antibody
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.9175
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 07611969205486
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