Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens. the vitek® ms system is a qualitative in vitro diagnostic device used in conjunction with other laboratory tests to aid in the diagnosis of bacterial, yeast and mould infections.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - mycoplasma ist 3 is a manual qualitative and semi-quantitative in vitro diagnostic test for the culture, identification,indicative enumeration and antibiotic susceptibility testing of mycoplasma hominis and ureaplasma spp. including ureaplasma parvum and ureaplasma urealyticum.it is intended as an aid to diagnosis and prediction of treatment response in adults suspected of having urogenital mycoplasma infection, using urethral swabs, vaginal and cervical swabs, semen and male urine samples. this assay is intended for use in clinical laboratories by laboratory health professionals.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - immunology - vidas® nephrocheck® is an automated test for use on the vidas® 3 instrument for the immunoenzymatic quantitative determination of timp‑2 (tissue inhibitor of metalloproteinase‑2) and igfbp‑7 (insulin-like growth factor‑binding protein 7) proteins in human urine using the elfa technique (enzyme linked fluorescent assay). the vidas® nephrocheck® assay is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment for moderate or severe acute kidney injury (aki) in acutely ill patients.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - vitek® ms prime is a mass spectrometry system using matrix-assisted laser desorption/ ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens. the vitek® ms prime system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. the vitek® ms prime system and this manual are intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.

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

biomerieux australia pty ltd - 48445 - hiv1/hiv2 antigen/antibody ivd, kit, enzyme immunoassay (eia) - an automated hiv infection screening test for use on the vidas family instruments, for the combined detection of anti-hiv-1 (groups m and o) and anti-hiv-2 total immunoglobulins and hiv-1 p24 antigen in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay). an automated hiv infection screening test for use on the vidas family instruments, for the combined detection of anti-hiv-1 (groups m and o) and anti-hiv-2 total immunoglobulins and hiv-1 p24 antigen in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay).

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray blood culture identification (bcid) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the filmarray instrument. the filmarray bcid panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. the filmarray bcid panel assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. results are intended to be interpreted in conjunction with gram stain results.the filmarray bcid panel is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia and results should be used in conjunction with other clinical and laboratory findings. positive filmarray results do not rule out co-infection with organisms not included in the filmarray bcid panel. the filmarray bcid panel is not intended to monitor treatment for bacteremia or fungemia.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray gastrointestinal (gi) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with filmarray systems. the filmarray gi panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in cary blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. the filmarray gi panel is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray instrument is an automated in vitro diagnostic device intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical samples. the instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex pcr in a closed system. the resulting pcr products are evaluated using dna melting analysis. the filmarray software automatically determines the results and provides a test report.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray meningitis/encephalitis (me) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with filmarray systems. the filmarray me panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (csf) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. the filmarray me panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. results from the filmarray me panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. filmarray me panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - filmarray respiratory panel (rp) is a multiplexed nucleic acid test intended for use with the filmarray instrument for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (nps) obtained from individuals suspected of respiratory tract infections. the following organism types and subtypes are identified using the filmarray rp: adenovirus, coronavirus 229e, coronavirus hku1, coronavirus nl63, coronavirus oc43, human metapneumovirus, influenza a, influenza a subtype h1, influenza a subtype h3, influenza a subtype h1-2009, influenza b, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, bordetella pertussis, chlamydophila pneumoniae, and mycoplasma pneumoniae. the results of this test should not be used as the sole basis for diagnosis, treatment, or other management decisions