Multiple-bacteria IVDs

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

から入手可能:

Bruker Pty Ltd

クラス:

Class 3

製:

Bruker Daltonics GmbH & Co KG Fahrenheitstrasse 4, Bremen, 28359 Germany

治療領域:

CT774 - Multiple-bacteria IVDs

適応症:

The Carbaplex IVD Real- Time PCR Kit (referred to as 'Carbaplex IVD PCR Kit') is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the qualitative detection of the five most prevalent families of carbapenemase genes. The assay detects and differentiates KPC, NDM, VIM, IMP and OXA-48- like gene targets, detecting nucleic acid extracted directly from rectal swab samples and bacterial cultures. The assay is intended for use by qualified laboratory individuals as an aid to identify carbapenemase-producing Enterobacteriaceae (CPE) that may colonise patients in healthcare settings. Parallel cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.

認証ステータス:

A

承認日:

2019-09-16