Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct910 - interpretive software ivds - the intended purpose of the bruker ivd maldi biotyper application (referred to as "ivdmaldi biotyper") is the calculation of the similarity of a mass spectrometry-based pattern profile of an unknown microorganism to mass spectrometry- based pattern profiles of characterized strains stored in a reference library. this allows identification of unknown microorganisms (bacteria, yeasts and fungi) at the species level after standardized sample preparation procedures, and detection of enzyme activity related to antibiotic resistance mechanisms.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct943 - instrument/analyser ivds - the maldi biotyper ivd systems are qualitative in vitro diagnostic matrix assisted laser desorption/ionization time of flight (maldi-tof) mass spectrometer for clinical use in conjunction with ivd software, reference libraries, reagents, and workflows.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct946 - general laboratory reagent and consumables ivds - the mbt sepsityper ivd kit is a sample preparation kit for the identification of microorganisms from positively flagged blood cultures using the maldi-tof mass spectrometer.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct943 - instrument/analyser ivds - the benchtop microflex instrument is a mass spectrometer which uses a technique called maldi (matrix- assisted laser desorption/ionization) reflector time- of-flight mass spectrometry. detectors. the instrument is designed for automated protein identification and characterization, biomarker detection, oligonucleotide quality control, and snp genotyping. it is intended to be used with the ivd maldi biotyper software and specific reagents (ivd bts and ivd hcca).

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct910 - interpretive software ivds - the ivd maldi biotyper is intended for the calculation of a similarity of a mass spectrometry based pattern profile of an unknown microorganism and mass spectrometry based pattern profiles of suitable characterized strains stored in a respective reference library in order to identify unknown microorganisms on species level, i.e. bacteria and yeasts after standardized sample preparation procedures. it is used in combination with the microflex mass spectrometer and specific reagents.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct946 - general laboratory reagent and consumables ivds - ivd bacterial test standard is a chemical composition containing an extract of the escherichia coli dh5? bacteria (inactivated) and two additional proteins. it is used by the ivd maldio biotyper to perform a quality control check of the microflex mass spectrometer settings. ivd matrix hcca-portioned is a cinnamic acid derivative. it enables easy and convenient preparation of maldi matrix for ivd mbt measurement and identification of test organism.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct1261 - microbial-isolate identification and testing ivds - the mbt star-bl product family kits are qualitative in vitro diagnostic medical devices indicated for use in conjunction with other clinical and laboratory findings to aid the rapid detection of a prevalent ?-lactamase activity towards selected microorganisms subcultured from human specimens using a benchmark antibiotic. analysis utilizes maldi tof (matrix-assisted laser desorption/ionization-time of flight)-based ivd maldi biotyper system and the mbt star-bl ivd module.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct937 - aspergillus ivds - the fungiplex aspergillus ivd real-time pcr kits are multiplex polymerase chain reaction (pcr) in vitro diagnostic (ivd) test for the qualitative detection of aspergillus dna extracted from edta whole blood, edta plasma, serum and bronchoalveolar lavage (bal) fluid obtained from human patients considered at risk of invasive fungal disease (ifd) and for use in conjunction with other clinical and laboratory findings to aid the rapid detection of aspergillus azole resistance markers in serum, plasma, bronchoalveolar lavage (bal) and directly from clinical isolates. the tests are intended for use by qualified laboratory individuals as an aid to the diagnosis of invasive aspergillosis, specifically of aspergillus spp. and a. terreus infections and upon a positive result as an aid to the stratification and guidance on available treatment options of patients infected by aspergillus fumigatus with the specific mutations of the cyp51a gene.the results of these tests should not be used as the sole basis for diagnosis, treatment or patient management decisions.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct802 - candida ivds - the fungiplex candida ivd real-time pcr kit (referred to as 'fungiplex candida ivd pcr kit') is a multiplex polymerase chain reaction (pcr) in vitro diagnostic (ivd) test for the qualitative detection of candida dna extracted from edta whole blood, edta plasma and serum obtained from human patients considered at risk of invasive fungal disease (ifd). the test is intended for use by qualified laboratory individuals as an aid to the diagnosis of invasive candidiasis, specifically of candida spp., c. glabrata and c. krusei infections. the results of this test should not be used as the sole basis for diagnosis, treatment or patient management decisions.

Australia - English - Department of Health (Therapeutic Goods Administration)

bruker pty ltd - ct774 - multiple-bacteria ivds - 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.