Beckman Coulter PK TP - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Beckman Coulter Australia Pty Ltd

Razred:

Class 4

Izdeluje:

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

Terapevtsko območje:

61225 - Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

Terapevtske indikacije:

BECKMAN COULTER PK TP SYSTEM is intended for the qualitative screening of blood donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum or EDTA plasma using the BECKMAN COULTER PK7300, Automated Microplate System. The test is based on the principle of agglutination and pattern recognition. The BECKMAN COULTER PK TP SYSTEM utilizes fixed chicken erythrocytes sensitized with components of the pathogenic T. pallidum

Status dovoljenje:

A

Datum dovoljenje:

2015-02-06