Infectious disease IVDs
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
19-07-2023
अनुरोध भेजा।
थमां उपलब्ध:
ZIP Diagnostics Pty Ltd
वर्ग:
Class 1
द्वारा बनाया गया:
ZIP Diagnostics Pty Ltd U2 19-29 & 24 Cromwell Street, Collingwood, VIC, 3066 Australia
चिकित्सीय क्षेत्र:
CT701 - Infectious disease IVDs
चिकित्सीय संकेत:
The ZiP-CoVx-P2 test is performed using the ZiP-P2 instrument. The test and instrument function together as a complete in vitro point-of-care diagnostic system. The test provides qualitative detection of SARS-CoV-2 RNA using isothermal nucleic acid amplification technology. The function of the ZiP-CoVx-P2 test is to aid diagnosis of COVID-19 in symptomatic individuals or to screen for SARS-CoV-2 infection in asymptomatic individuals. The test is intended for use by healthcare professionals in dedicated test spaces (e.g. hospital emergency, intensive care, general practice, antiviral treatment clinics, or other sites established for screening and testing purposes). The test can also be used by laboratory-trained professionals in pathology settings. Minimal training is required as the test is menu-driven with a screen-prompted automated workflow that includes result interpretation and reporting. A synthetic flocked swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample. Dry swab samples must be used because swabs in liquid transport media may interfere with test performance.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2023-02-07
