Summary for ARTG Entry:
Cepheid Holdings Pty Ltd - Staphylococcus IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Cepheid Holdings Pty Ltd
23-27 Chaplin Drive,Lane Cove West, NSW, 2066
ARTG Start Date
Medical Device Class 3
- 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
CT797 Staphylococcus IVDs
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
No Specific Conditions included on Record
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Produced at 09.11.2017 at 11:45:42 AEDT
This is not an ARTG Certificate document.
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