Staphylococcus

Main information

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

Documents

Localization

  • Available in:
  • Staphylococcus IVDs
    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

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

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...

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety