Reagent red blood cell IVDs

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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08-11-2017

MAH:

Beckman Coulter Australia Pty Ltd

class:

Class 4

manufactured_by:

Beckman Coulter Inc 250 South Kraemer Boulevard, Brea, CA, 92821 United States Of America

therapeutic_area:

CT886 - Reagent red blood cell IVDs

therapeutic_indication:

The test is based on hemagglutination principles. Reagent red blood cells with specific antigens agglutinate in the presence of corresponding antibodies contained in donor plasma. The absence of agglutination indicates the absence of the specific antibody in the donor plasma. The analyzers read the settling patterns and make a determination. The BECKMAN COULTER? PK? System Reagent Red Blood Cels (A1 and B) are intended for the determination of the reverse or plasma group on the BECKMAN COULTER PK7200 and PK7300 Automated Analyzers.

authorization_status:

Included - IVD