Curetis Unyvero BCU Blood Culture Application

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ACUMEN RESEARCH LABORATORIES PTE. LTD.

Class:

Class C IVD

Manufactured by:

Curetis GmbH

Therapeutic area:

Microbiology

Therapeutic indications:

The Unyvero BCU application used with the Unyvero System is a DNA test for the simultaneous detection of multiple pathogen-associated nucleic acids in positive blood cultures from patients with signs and symptoms of a bloodstream infection, with the aim of providing information about the pathogen species and antibiotic resistance genes. The identification of specific pathogen DNA helps in the diagnosis of these infections caused by bacteria and/or fungi, if these results are used in conjunction with other clinical or laboratory methods. Additional cultures are required to cultivate microorganisms for further determination of antibiotic resistance. It is recommended that samples that have tested negative for microorganisms and antibiotic resistance genes with the Unyvero BCU application are retested using microbiological cultures. Positive findings do not rule out co-infections. The Unyvero result should not be used alone for diagnosis and patient management.

Product summary:

Device System Info:[System or Procedure Pack], Fluorescence intensities from probe-hybridized PCR amplification products are measured to indicate the presence of microorganisms and/or antibiotics resistance genes. Unyvero instruments and the BCU application are always used together as an IVD SYSTEM.; Models: Unyvero BCU Blood Culture Cartridge Set - 10077, Unyvero BCU Blood Culture Cartridge - 10076, Unyvero B1 Sample Tube & B1 Sample Tube Cap - 10067, Unyvero B1 Sample Tube & B1 Sample Tube Cap Set - 10068, Unyvero B1 Collection Tube - 10058, Unyvero B1 Collection Tube Set - 10061, Unyvero M1 Master Mix Tube - 10002, Unyvero M1 Master Mix Tube Set - 10011, Unyvero Sample Tube Holder - 60010, Unyvero A50 Analyzer - 60001, Unyvero C8 Cockpit - 60003, Unyvero L4 Lysator - 60002

Authorization date:

2018-04-04