Summary for ARTG Entry:
Cepheid Holdings Pty Ltd - Multiple-viruses 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. Multiple-viruses IVDs
CT702 Multiple-viruses IVDs
The Cepheid® Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the
GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal
fluid (CSF) specimens from individuals with signs and symptoms of meningitis. This test, in conjunction
with other laboratory results and clinical information, may be used as an aid in the laboratory diagnosis of
enterovirus infection in patients with a clinical suspicion of meningitis or meningoencephalitis. Assay
performance characteristics have not been established for immunocompromised or immunosuppressed
CAUTION: The results obtained with the Xpert EV assay should be used only as an adjunct to clinical
observations and other information available to the physician. Positive Xpert EV results do not rule out
other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g., herpes family viruses,
arboviruses, mumps virus, etc.), and fungi.
No Specific Conditions included on Record
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