Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.
Referencells - 0066900

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: 10888234001522

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