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

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Laporan Penilaian Awam (PAR)
23-11-2017

Boleh didapati daripada:

Beckman Coulter Australia Pty Ltd

Kelas:

Class 4

Dikeluarkan oleh:

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

Kawasan terapeutik:

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

Tanda-tanda terapeutik:

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 kebenaran:

A

Tarikh kebenaran:

2015-02-06

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