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CINtec® PLUS Cytology Kit

Japan

IVD For in vitro diagnostic use.
CINtec<sup>®</sup> <i>PLUS</i> Cytology Kit
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    IVD For in vitro diagnostic use.
    CINtec<sup>®</sup> <i>PLUS</i> Cytology Kit
    CINtec® PLUS Cytology Kit CE-IVD The CINtec PLUS Cytology Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations. It is indicated to be used as an aid in the identification of women with high-grade cervical intraepithelial lesions in a screening population, and in the sub-groups of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low-grade squamous intraepithelial lesion), or in patients with positive high-risk HPV test results.Interpretation of the test results may only be made by a certified professional in conjunction with the patient´s clinical history and additional diagnostic tests that have been performed.The product is intended for in vitro diagnostic (IVD) use.  
    IVD For in vitro diagnostic use.
    CINtec<sup>®</sup> <i>PLUS</i> Kit
    CINtec® PLUS Kit CE-IVD The CINtec® PLUS Kit is an immunocytochemistry assay for the simultaneous qualitative detection of the p16INK4a and Ki-67 proteins in cervical cytology preparations.It is intended to be used as an aid in the identification of women with high-grade cervical intraepithelial lesions in a screening population, and in the sub-groups of patients with a Pap cytology result of ASC-US (atypical squamous cells of undetermined significance) or LSIL (low grade squamous intraepithelial lesion), or in patients with positive high-risk HPV test results.The kit is intended to be used in medical cytology laboratories. Interpretation of the test results may only be made by a certified professional in conjunction with the patient 's clinical history and additional diagnostic tests that have been performed.The test is intended for manual use, or for use on Autostainer instruments.
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