cobas® HCV - India CDSCO Medical Device Registration

Product Information

cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (cobas® HCV) RNA, in human EDTA plasma or serum, of HCV-infected individuals. Samples containing HCV genotype 1 to 6 are validated for detection and quantitation in the assay. The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results must be interpreted within the context of all relevant clinical and laboratory finding.,cobas® HIV-1(cobas® HCV)-cobas®HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (cobas® HCV) in EDTA plasma or from a cobas® Plasma Separation Card (cobas® HCV) dried plasma spot and for the qualitative detection of HIV-1 in dried blood spots of HIV-1-infected individuals including infants born to mothers infected with HIV-1. The test is to be used with cobas® 4800 System.This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management of HIV-1-infected patients. When used as a quantitative test, this test can be used as an aid in diagnosis for confirmation of HIV-1 infection in antibody reactive individuals and 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. When used as a qualitative test with dried blood spots, detection of HIV-1 nucleic acids is indicative of active HIV-1 infection in infants born to HIV-infected mothers who have maternal antibodies to HIV-1. This test can also be used for confirmation of HIV-1 infection in individuals reactive for HIV-1 antibodies or antigens. ,cobas® HCV GT(cobas® HCV)-cobas® HCV GT is an in vitro nucleic acid amplification test for the qualitative identification of Hepatitis C Virus (cobas® HCV) genotypes 1 to 6 and genotype 1 subtypes a and b in human EDTA plasma or serum from individuals with chronic HCV infection, using the cobas® 4800 system: the cobas x 480 instrument for automated sample processing and the cobas z 480 analyzer for automated amplification and detection. cobas® HCV GT is intended for use in selecting individuals with chronic HCV infection for antiviral therapy and in determining the duration of therapy regimens according to the antiviral therapy prescribing information,cobas® 4800 HBV/HCV/HIV-1 Control Kit(cobas® HCV)-cobas® 4800 HBV/HCV/HIV-1 Control Kit contains plasma derived from human blood. The source material has been tested by a licensed antibody test and found to be non-reactive for the presence of antibody to HCV, antibody to HIV-1/2, antibody to HBsAg and antibody to HBc. Testing by PCR methods showed no detectable HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA. No known test method can offer complete assurance that products derived from human blood will not transmit infectious agents.,cobas® 4800 HCV GT Control Kit(cobas® HCV)-cobas® HCV GT Control Kit contains plasma derived from human blood. The source material has been tested by licensed serology tests and found to be non-reactive for antibody to HCV, antibody to HIV- 1/2, HBsAg and antibody to HBc. Testing by PCR methods showed no detectable HIV-1, HIV-2 RNA, HCV RNA, and HBV DNA. No known test method can offer complete assurance that products derived from human blood will not transmit infectious agents.,cobas® HBV(cobas® HCV)-cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (cobas® HCV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.,cobas® HBV/HCV/HIV-1 Control Kit(cobas® HBV/HCV/HIV-1 Control Kit (cobas® HCV))-cobas® HBV/HCV/HIV-1 Control Kit will be used with the main kits on the cobas 6800/8800 system,cobas® HIV-1(cobas® HCV)-cobas®HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (cobas® HCV) in EDTA plasma or from a cobas® Plasma Separation Card (cobas® HCV) dried plasma spot and for the qualitative detection of HIV-1 in dried blood spots of HIV-1-infected individuals including infants born to mothers infected with HIV-1. The test is to be used with cobas® 4800 System.This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management of HIV-1-infected patients. When used as a quantitative test, this test can be used as an aid in diagnosis for confirmation of HIV-1 infection in antibody reactive individuals and 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. When used as a qualitative test with dried blood spots, detection of HIV-1 nucleic acids is indicative of active HIV-1 infection in infants born to HIV-infected mothers who have maternal antibodies to HIV-1. This test can also be used for confirmation of HIV-1 infection in individuals reactive for HIV-1 antibodies or antigens. ,cobas® HBV(cobas® HCV)-cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (cobas® HCV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.,cobas® HCV(cobas® HCV)-cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (cobas® HCV) RNA, in human EDTA plasma or serum, of HCV-infected individuals. Samples containing HCV genotype 1 to 6 are validated for detection and quantitation in the assay. The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results must be interpreted within the context of all relevant clinical and laboratory finding.,cobas® 4800 HCV GT Control Kit(cobas® HCV)-cobas® HCV GT Control Kit contains plasma derived from human blood. The source material has been tested by licensed serology tests and found to be non-reactive for antibody to HCV, antibody to HIV- 1/2, HBsAg and antibody to HBc. Testing by PCR methods showed no detectable HIV-1, HIV-2 RNA, HCV RNA, and HBV DNA. No known test method can offer complete assurance that products derived from human blood will not transmit infectious agents.,cobas® 4800 HBV/HCV/HIV-1 Control Kit(cobas® HCV)-cobas® 4800 HBV/HCV/HIV-1 Control Kit contains plasma derived from human blood. The source material has been tested by a licensed antibody test and found to be non-reactive for the presence of antibody to HCV, antibody to HIV-1/2, antibody to HBsAg and antibody to HBc. Testing by PCR methods showed no detectable HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA. No known test method can offer complete assurance that products derived from human blood will not transmit infectious agents.,cobas® HCV GT(cobas® HCV)-cobas® HCV GT is an in vitro nucleic acid amplification test for the qualitative identification of Hepatitis C Virus (cobas® HCV) genotypes 1 to 6 and genotype 1 subtypes a and b in human EDTA plasma or serum from individuals with chronic HCV infection, using the cobas® 4800 system: the cobas x 480 instrument for automated sample processing and the cobas z 480 analyzer for automated amplification and detection. cobas® HCV GT is intended for use in selecting individuals with chronic HCV infection for antiviral therapy and in determining the duration of therapy regimens according to the antiviral therapy prescribing information,cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 Systems (cobas® HCV)-cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C (cobas® HCV) RNA, genotypes 1 to 6, in human EDTA plasma or serum of HCV-infected individuals. cobas® HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The test is intended for use in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (cobas® HCV) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (cobas® HCV) as measured by changes of HCV RNA levels in serum or EDTA plasma. The results must be interpreted within the context of all relevant clinical and laboratory finding.,cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 Systems(cobas® HCV)-cobas® HBV is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (cobas® HCV) DNA in human EDTA plasma or serum of HBV-infected individuals. This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from cobas® HBV must be interpreted within the context of all relevant clinical and laboratory findings.,cobas® MPX(cobas® HCV)-The cobas® MPX test, for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (cobas® HCV) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (cobas® HCV) RNA, Hepatitis C Virus (cobas® HCV) RNA, and Hepatitis B Virus (cobas® HCV) DNA in human plasma and serum. This test is intended for use to screen donor samples for HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA, and HBV DNA in plasma and serum samples from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor's heart is still beating and in testing of cadaveric (cobas® HCV) donors. Plasma and serum from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma and serum samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples. For donations from cadaveric (cobas® HCV) organ and tissue donors, samples may only be screened as individual sample. For an individual sample, results are simultaneously detected and discriminated for HIV, HCV, and HBV. The cobas® MPX test can be considered a supplemental test that confirms HIV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HIV and reactive on the cobas® MPX test. The cobas® MPX test can be considered a supplemental test that confirms HCV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HCV and reactive on the cobas® MPX test. The cobas® MPX test can be considered a supplemental test that confirms HBV infection for samples that are repeatedly reactive on a CE-IVD test for Hepatitis B surface antigen and reactive on the cobas® MPX test. This test is not intended for use as an aid in diagnosis of infection with HIV, HCV, or HBV.,cobas® MPX Control Kit(cobas® HCV)-The cobas MPX control kit is to be used in conjunction with the cobas® MPX test on cobas® 6800 and cobas® 8800 Systems,cobas® HIV-1 Quantitative nucleic acid test for use on the cobas® 6800/8800 Systems(cobas® HCV)-cobas® HIV-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (cobas® HCV) in EDTA plasma or from a cobas® Plasma Separation Card (cobas® HCV) dried plasma spot of HIV-1-infected individuals. This test is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of HIV-1-infected patients. This test can be used for confirmation of HIV-1 infection in antibody reactive individuals and to assess patient prognosis by measuring the baseline HIV-1 level or to monitor the effects of antiretroviral therapy by measuring changes in HIV-1 RNA levels during the course of antiretroviral treatment.,cobas® MPX Control Kit(cobas® HCV)-The cobas MPX control kit is to be used in conjunction with the cobas® MPX test on cobas® 6800 and cobas® 8800 Systems,cobas® MPX(cobas® HCV)-The cobas® MPX test, for use on cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (cobas® HCV) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (cobas® HCV) RNA, Hepatitis C Virus (cobas® HCV) RNA, and Hepatitis B Virus (cobas® HCV) DNA in human plasma and serum. This test is intended for use to screen donor samples for HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA, and HBV DNA in plasma and serum samples from individual human donors, including donors of whole blood, blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor's heart is still beating and in testing of cadaveric (cobas® HCV) donors. Plasma and serum from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma and serum samples may be tested individually or plasma may be tested in pools comprised of aliquots of individual samples. For donations from cadaveric (cobas® HCV) organ and tissue donors, samples may only be screened as individual sample. For an individual sample, results are simultaneously detected and discriminated for HIV, HCV, and HBV. The cobas® MPX test can be considered a supplemental test that confirms HIV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HIV and reactive on the cobas® MPX test. The cobas® MPX test can be considered a supplemental test that confirms HCV infection for samples that are repeatedly reactive on a CE-IVD test for antibodies to HCV and reactive on the cobas® MPX test. The cobas® MPX test can be considered a supplemental test that confirms HBV infection for samples that are repeatedly reactive on a CE-IVD test for Hepatitis B surface antigen and reactive on the cobas® MPX test. This test is not intended for use as an aid in diagnosis of infection with HIV, HCV, or HBV