Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Bruker Pty Ltd - Multiple-bacteria IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Bruker Pty Ltd
PO Box 8432,NORTHLAND CENTRE, VIC, 3072
ARTG Start Date
Medical Device Class 3
Bruker Daltonik GmbH
, Bremen, 28359
1. Multiple-bacteria IVDs
CT774 Multiple-bacteria IVDs
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.
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 08.11.2019 at 10:32:06 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information