Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - clinical chemistry - the variant™ ii turbo hba1c kit - 2.0 is intended for the quantitative determination of hemoglobin a1c (ifcc mmol/mol and ngsp %) in human whole blood using ion-exchange high-performance liquid chromatography (hplc) on the variant ii turbo hemoglobin testing system and variant ii turbo link hemoglobin testing system. this test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. measurement of hemoglobin a1c is effective in monitoring long‑term glycemic control in individuals with diabetes mellitus. the variant ii turbo hba1c kit - 2.0 is intended for professional use only. the hemoglobin capillary collection system (hccs) is intended for the collection of human whole blood for the percent determination of hemoglobin a1c using bio-rad hplc methods.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - immunology - the bio-rad vma by column test is designed for the quantitative measurement of vanilmandelic acid in urine. for in vitro diagnostic use.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - immunology - the bio-rad vma/hva/5-hiaa by hplc test is designed for the quantitative measurement of vanilmandelic acid, homovanillic acid and 5-hydroxy-indoleacetic acid in human urine.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - immunology - the bioplex® 2200 ebv igg kit is a multiplex flow immunoassay intended for the qualitative detection of igg antibodies to three (3) separate ebv antigens; epstein-barr virus nuclear antigen-1 (ebv na-1), viral capsid antigen (ebv vca), and early antigen diffuse (ebv ea-d) in human serum. the test system can be used in conjunction with the bioplex 2200 ebv igm kit as an aid in the laboratory diagnosis of infectious mononucleosis (im). the ebv igg kit is intended for use with the bio-rad bioplex 2200 system. assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, burkitt’s lymphoma, and other ebv-associated lymphomas.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - immunology - the bioplex® 2200 ebv igm kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; epstein-barr virus viral capsid antigen igm (ebv vca igm) antibodies and heterophile antibodies in human serum. the test system can be used in conjunction with the bioplex 2200 ebv igg kit as an aid in the laboratory diagnosis of infectious mononucleosis (im). the ebv igm kit is intended for use with the bio-rad bioplex 2200 system. assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, burkitt’s lymphoma, and other ebv-associated lymphomas.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - obstetrics & gynaecology - the bioplex 2200 torc igm kit is a multiplex flow immunoassay intended for the qualitative detection of igm antibodies to toxoplasma gondii (t. gondii), rubella, and cytomegalovirus (cmv) in human serum and potassium edta or heparinized plasma. the bioplex 2200 torc igm kit is intended for use with the bio-rad bioplex 2200 system. this kit is intended as an aid in the diagnosis of a current or recent t. gondii, rubella and/or cmv infection, in individuals suspected of having one of the respective disease states, including women of child-bearing age.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - hematology - the qxdx bcr-abl %is test, performed on bio-rad’s qxdx droplet digital pcr system, is an in vitro nucleic acid amplification test for the quantitation of bcr-abl1 and abl1 transcripts in total rna from whole blood of diagnosed t(9;22) positive chronic myeloid leukemia (cml) patients expressing bcr-abl1 fusion transcripts type e13a2 and/or e14a2. the test measures the e13a2 and/or e14a2 transcripts of bcr-abl1, normalized to the abl1 endogenous control. results are reported as percent reduction from a baseline of 100% on the international scale (%is) and on a log molecular reduction (mr) scale. the test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). this test is not intended for the diagnosis of cml.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - microbiology - amplichek ii is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nuclei acid testing procedures for the qualitative detection of methicillin resistant staphylococcus aureus, methicillin sensitive staphylococcus aureus, clostridium difficile and vancomycin-resistant enterococci performed on cepheid genexpert systems. this product is not intended to replace manufacturer controls provided with the device. this product is only for use with assays and instruments listed in the representative results chart in this labeling.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - microbiology - it is intended for the detection and identification of legionella pneumophila in clinical specimens and culture.

Singapore - inglese - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - microbiology - it is a qualitative and semi-quantitative test which uses a simple agglutination technique to detect the capsular polysaccharide of cryptococcus neoformans, glycuronoxylomannan (gxm), in biological fluids (serum,csf, bal, urine).