Multiple-bacteria IVDs

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Boleh didapati daripada:

Bruker Pty Ltd

Kelas:

Class 3

Dikeluarkan oleh:

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

Kawasan terapeutik:

CT774 - Multiple-bacteria IVDs

Tanda-tanda terapeutik:

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.

Status kebenaran:

A

Tarikh kebenaran:

2019-09-16