Multiple-bacteria IVDs

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Bruker Pty Ltd

Klasse:

Class 3

Produsert av:

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

Terapeutisk område:

CT774 - Multiple-bacteria IVDs

Indikasjoner:

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.

Autorisasjon status:

A

Autorisasjon dato:

2019-09-16