Staphylococcus IVDs

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Cepheid Holdings Pty Ltd

Class:

Class 3

Manufactured by:

Cepheid 904 Caribbean Drive, Sunnyvale, California, 94089 United States Of America

Therapeutic area:

CT797 - Staphylococcus IVDs

Therapeutic indications:

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

Authorization status:

A

Authorization date:

2014-03-31