Multiple-bacteria IVDs

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné s:

Bruker Pty Ltd

Třída:

Class 3

Výrobce:

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

Terapeutické oblasti:

CT774 - Multiple-bacteria IVDs

Terapeutické indikace:

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.

Stav Autorizace:

A

Datum autorizace:

2019-09-16