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

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
23-11-2017

から入手可能:

Beckman Coulter Australia Pty Ltd

クラス:

Class 4

製:

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

治療領域:

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

適応症:

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

認証ステータス:

A

承認日:

2015-02-06

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