Main information

  • Trade name:
  • Staphylococcus IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Staphylococcus IVDs
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221810
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Cepheid Holdings Pty Ltd - Staphylococcus IVDs

ARTG entry for

Medical Device Included - IVD Class 3


Cepheid Holdings Pty Ltd

Postal Address

23-27 Chaplin Drive,Lane Cove West, NSW, 2066


ARTG Start Date


Product category

Medical Device Class 3



Approval area


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.





904 Caribbean Drive

Sunnyvale, California, 94089

United States Of America


1. Staphylococcus IVDs

Product Type

Effective date



CT797 Staphylococcus IVDs

Intended purpose

The Xpert MRSA and MRSA NxG, is a qualitative IVD for the detection of methicillin-resistant S. aureus

DNA from nasal swabs. The test utilizes automated real-time PCR for the amplification of MRSA specific

DNA targets. The Xpert MRSA and MRSA NxG is intended to aid in the prevention and control of MRSA

infections in healthcare settings. The Xpert MRSA and MRSA NxG are not intended to diagnose, guide, or

monitor treatment for MRSA infections, or provide results of susceptibility to methicillin

Specific Conditions

No Specific Conditions included on Record

© 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

Public Summary

Page 1 of

Produced at 09.11.2017 at 11:45:42 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.

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