Positive Control for Solidscreen II on TANGO instruments; 4 ml
Solidscreen II-Control - 806514100
Device Description
A material containing antibodies to Rh(D) red blood cell antigens [RH001] from the Rhesus system intended to be used in immunohaematological testing of a clinical specimen, to verify the performance of an antibody screening assay that is used for detecting red cell alloantibodies.
Environmental Conditions
- 8.00
- 2.00
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 Identifiers
Device Id: 07611969951390
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