The IH
IH-Card ABO Neutral - 12008722
Device Description
A non-reactive suspension medium containing beaded particles, with or without added agglutination enhancing reagents (e.g., LISS, enzymes), presented as a a set of gels or solid phase columns and intended to be used in testing a clinical specimen for red blood cell antigens and/or antibodies, using a column agglutination technique.
Environmental Conditions
- 25.00
- 18.00
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: 03610522055685
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