Multiple-bacteria IVDs
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
08-11-2019
अनुरोध भेजा।
थमां उपलब्ध:
Bruker Pty Ltd
वर्ग:
Class 3
द्वारा बनाया गया:
Bruker Daltonics GmbH & Co KG Fahrenheitstrasse 4, Bremen, 28359 Germany
चिकित्सीय क्षेत्र:
CT774 - Multiple-bacteria IVDs
चिकित्सीय संकेत:
The Carbaplex IVD Real- Time PCR Kit (referred to as 'Carbaplex IVD PCR Kit') is a multiplex polymerase chain reaction (PCR) in vitro diagnostic (IVD) test for the qualitative detection of the five most prevalent families of carbapenemase genes. The assay detects and differentiates KPC, NDM, VIM, IMP and OXA-48- like gene targets, detecting nucleic acid extracted directly from rectal swab samples and bacterial cultures. The assay is intended for use by qualified laboratory individuals as an aid to identify carbapenemase-producing Enterobacteriaceae (CPE) that may colonise patients in healthcare settings. Parallel cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2019-09-16
