Immunohaematology blood grouping antisera IVDs

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Grifols Australia Pty Ltd

Klass:

Class 3

Tillverkad av:

Medion Grifols Diagnostics AG Bonnstrasse 9, DUDINGEN, CH3186 Switzerland

Terapiområde:

CT887 - Immunohaematology blood grouping antisera IVDs

Terapeutiska indikationer:

Anti-Lea for DG Gel and Anti-Leb for DG Gel are monoclonal antisera for gel technique to identify the Lea and Leb antigen on erythrocytes. The Lewis antigens, Lea and Leb, are glycosphingolipids present in saliva and plasma. Erythrocytes acquire their Lewis phenotype by adsorbing Lewis antigens from plasma. Anti-P1 Mono-Type? Dual is a monoclonal antiserum for tube test and gel technique to identify the P1 antigen on erythrocytes. Of the three phenotypes P1, P2 and p (Tja-) in the P system, P1 is mostly looked for. Due to the varying strength of reactions, the P1 antigen may be graduated as P1 strong, P1 medium and P1 weak although these divisions of strength are more arbitrary than based on any demonstrable quantitative or qualitative differences.

Bemyndigande status:

A

Tillstånd datum:

2022-01-21