Tanzania - English - Tanzania Medicinces & Medical Devices Authority

africa biosystems tanzania ltd, tanzania - taqman snp genotyping assay -

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

roche diagnostics australia pty limited - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - the cobas? ampliprep/cobas? taqman? hcv qualitative test, v2.0 is a nucleic acid amplification test for the detection of hcv rna in human serum or edta plasma. automated specimen preparation isolates hcv rna followed by rt of target and simultaneous pcr using the cobas? ampliprep instrument with amplification and detection automated using the cobas? taqman? analyzer or the cobas? taqman? 48 analyzer. the cobas? ampliprep/cobas? taqman? hcv qualitative test, v2.0 is a qualitative in vitro nucleic acid amplification test for the detection of hepatitis c virus rna genotypes 1 to 6 using the cobas? ampliprep instrument and the cobas? taqman? analyzer or the cobas? taqman? 48 analyzer. the assay is indicated for patients who are suspected to be actively infected with hcv and can be used to confirm antibody positive specimens. the assay is not intended for use as a screening test for the presence of hcv in blood or blood products.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the cobas ampliprep/cobas taqman hbv test is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human plasma, using the cobas ampliprep instrument for automated specimen processing and the cobas taqman analyzer or cobas taqman 48 analyzer for automated amplification and detection. this test is intended for use in conjunction with clinical presentation and other laboratory markers as an aid in assessing viral response to antiviral treatment as measured by changes in plasma hbv dna levels. the cobas ampliprep/cobas taqman hbv test is not intended for use as a screening test for the presence of hbv in blood or blood products or as a diagnostic test to confirm the presence of hbv infection.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the cobas taqman ct test v2.0 is an in vitro nucleic acid amplification test for the qualitative detection of chlamydia trachomatis dna in female endocervical swab specimens or male and female urine, using the amplicor ct/ng specimen preparation kit for manual specimen preparation and the cobas taqman 48 analyzer for automated amplification and detection.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the cobas taqman hiv-1 test, version 2.0 (v2.0) for use with the high pure system is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (hiv-1) rna in human edta plasma, using the high pure system viral nucleic acid kit for manual specimen preparation and the cobas taqman 48 analyzer for automated amplification and detection.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the cobas® taqman® hcv test, v2.0 for use with the high pure system (hps) is an in vitro nucleic acid amplification test for the quantitation of hepatitis c virus (hcv) rna genotypes 1 through 6 in human serum or plasma, using the high pure system viral nucleic acid kit for manual specimen preparation and the cobas® taqman® 48 analyzer for automated amplification and detection. the test is intended for use in conjunction with clinical presentation and other laboratory markers as an aid in assessing viral response to antiviral treatment as measured by changes in serum or plasma hcv rna levels. recent data suggest that early changes in serum/plasma hcv rna levels may predict long-term response to interferon therapy. the cobas® taqman® hcv test, v2.0 is not intended for use as a screening test for the presence of hcv in blood or blood products or as a diagnostic test to confirm the presence of hcv infection.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - it is an in vitro nucleic acid amplification test for the quantitation of hepatitis c virus (hcv) rna in human plasma or serum using the cobas ampliprep instrument for automated specimen processing and the cobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification and detection. the test is intended for use in conjunction with clinical presentation and other laboratory markers of hcv infection for the clinical management of patients with chronic hcv. the test can be used to assess the probability of a sustained viral response early in a course of antiviral therapy and to assess viral response to antiviral treatment as measured by changes in serum or plasma hcv rna levels.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the cobas® ampliprep/cobas® taqman® hbv test, version 2.0 (v2.0) is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human plasma and serum, using the cobas® ampliprep instrument for automated specimen processing and the cobas® taqman® analyzer or cobas® taqman® 48 analyzer for automated amplification and detection. this test is intended for use as an aid in the management of patients with chronic hbv infection undergoing anti-viral therapy. the assay can be used to measure hbv dna levels at baseline and during treatment to aid in assessing response to treatment. the results from the cobas® ampliprep/cobas® taqman® hbv test, v2.0 must interpreted within the context of all relevant clinical and laboratory findings.the cobas® ampliprep/cobas® taqman® hbv test, v2.0 is not intended for use as a screening test for the presence of hbv in blood or blood products or as a diagnostic test to confirm the presence of hbv infection.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - it is a qualitative in vitro nucleic acid amplification test for the detection of hepatitis c virus (hcv) rna genotypes 1 to 6 in human edta plasma or serum using the cobas® ampliprep instrument for automated specimen processing and the cobas® taqman® analyzer or the cobas® taqman® 48 analyzer for automated amplification and detection. it is indicated for patients who have clinical and/or biochemical evidence of liver disease and antibody evidence of hcv infection, and who are suspected to be actively infected with hcv. the test can be used to confirm antibody positive specimens. detection of hcv rna indicates that the virus is replicating and therefore is evidence of active infection. it is not intended for use as a screening test for the presence of hcv in blood or blood products.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - microbiology - the device is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (hiv-1) rna in human edta plasma using the cobas® ampliprep instrument for automated specimen processing and the cobas® taqman® analyzer or cobas® taqman® 48 analyzer for automated amplification and detection. the cobas® ampliprep/cobas® taqman® hiv-1 test, v2.0 is not intended for use as a screening test for the presence of hiv-1 in blood or blood products or as a diagnostic test to confirm the presence of hiv-1 infection. this test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of hiv-1 group m and hiv-1 group o infected patients. the test can be used to assess patient prognosis by measuring the baseline hiv-1 rna level or to monitor the effects of antiretroviral therapy by measuring changes in hiv-1 rna levels during the course of antiretroviral treatment.