Staphylococcus IVDs

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
09-11-2017

から入手可能:

Cepheid Holdings Pty Ltd

クラス:

Class 3

製:

Cepheid 904 Caribbean Drive, Sunnyvale, California, 94089 United States Of America

治療領域:

CT797 - Staphylococcus IVDs

適応症:

The Xpert MRSA and MRSA NxG, is a qualitative IVD for the detection of methicillin-resistant S. aureus DNA from nasal swabs. The test utilizes automated real-time PCR for the amplification of MRSA specific DNA targets. The Xpert MRSA and MRSA NxG is intended to aid in the prevention and control of MRSA infections in healthcare settings. The Xpert MRSA and MRSA NxG are not intended to diagnose, guide, or monitor treatment for MRSA infections, or provide results of susceptibility to methicillin

認証ステータス:

A

承認日:

2014-03-31

この製品に関連するアラートを検索

ドキュメントの履歴を表示する