Multiple-bacteria IVDs

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Bruker Pty Ltd

class:

Class 3

manufactured_by:

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

therapeutic_area:

CT774 - Multiple-bacteria IVDs

therapeutic_indication:

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.

authorization_status:

A

authorization_date:

2019-09-16