Multiple-bacteria IVDs

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Bruker Pty Ltd
Class:
Class 3
Authorization status:
Included - IVD
Authorization number:
323582

Public Summary

Summary for ARTG Entry:

323582

Bruker Pty Ltd - Multiple-bacteria IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Bruker Pty Ltd

Postal Address

PO Box 8432,NORTHLAND CENTRE, VIC, 3072

Australia

ARTG Start Date

16/09/2019

Product category

Medical Device Class 3

Status

Active

Approval area

Manufacturers

Name

Address

Bruker Daltonik GmbH

Fahrenheitstrasse 4

, Bremen, 28359

Germany

Products

1. Multiple-bacteria IVDs

Product Type

Effective date

16/09/2019

GMDN

CT774 Multiple-bacteria IVDs

Intended purpose

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.

Specific Conditions

© 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.

Public Summary

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

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