Capture-R Ready-Screen (3) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.

Capture
Capture-R Ready-Screen 3 - 0066901

A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid-phase red blood cell adherence method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QHT

Device Name: Reagent Red Blood Cells

Device Class: U

Physical State: Sourced from human blood

Definition: For the detection of or identification of human blood-group antibodies

Submission Type ID: 3

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antigen and antibody reaction by hemagglutination, column agglutination (gel technique), solid phase or microplate

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: Serum or plasma

Regulation Number: 660.30

Third Party Flag: N

Medical Specialty: HE

Device Id: 10888234001539

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