Staphylococcus
Main information
- Trade name:
- Staphylococcus IVDs
- Available from:
- Cepheid Holdings Pty Ltd
- Class:
- - IVD Class 3
- Medicine domain:
- Humans
- Medicine type:
- Medical device
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- 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:
221810
Cepheid Holdings Pty Ltd - Staphylococcus IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Sponsor
Cepheid Holdings Pty Ltd
Postal Address
23-27 Chaplin Drive,Lane Cove West, NSW, 2066
Australia
ARTG Start Date
31/03/2014
Product category
Medical Device Class 3
Status
Active
Approval area
Conditions
- 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.
Manufacturers
Name
Address
Cepheid
904 Caribbean Drive
Sunnyvale, California, 94089
United States Of America
Products
1. Staphylococcus IVDs
Product Type
Effective date
31/03/2014
GMDN
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 http://www.tga.gov.au/about/website-copyright.htm.
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.
Visit www.tga.gov.au for contact information
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Documents in other languages are available here
- Access to this document is only available to registered users.
Register now for full access
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Manual for reporting on antimicrobial resistance within the framework of Directive 2003/99/EC and Decision 2013/652/EU for information derived from the year 2018
Published on: Wed, 30 Jan 2019 This manual provides guidance for reporting antimicrobial resistance under the framework of Directive 2003/99/EC and Commission Implementing Decision 2013/652/EU in food‐producing animals and foodstuffs derived thereof. The objective is to harmonise and streamline the reporting made by the Member States to ensure that the antimicrobial resistance data collected are relevant and easy to analyse at the European Union level. Detailed guidelines are provided for the reporting ...
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HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...
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