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The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Card device (also The VicTorch hCG Test Card) is designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now bolor only gated "immal test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCG/ml of human urine. VicTorch hCG Test Card devices are intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of hCG, a placental hormone that may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Card devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Card devices are designed for professional use only, and provide only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The VicTorch hCG Test Card device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) on the cutoff level of 20 mlUml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Cards are used to aid in the diagnosis of pregnancy.

The VicTorch Meditek Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Strip device (also rne vioron moditor Haman Sherion's designed as a rapid in vitro diagnostic (IVD) qualitative lateral flow color-conjugated immuno-chromatographic (CCI) assay for the early detection of pregnancy, now done ourick direct visual test for the placental hormone, hCG, at the required cut-off level of 20 mlU hCGml of human urine. VicTorch hCG Test Strip devices are intended to meet all requirements for rioUing rapid, easily read, qualitative results for the purpose of early pregnancy detection via CCI assay of ylolang rapid, outlif rodal quality of the may be present in human plasma or urine, according to the requirements set forth in Title 21, section 862.1155 of the Code of Federal Regulation or CFR, and in subsequent federal Guidance Documents. VicTorch hCG Test Strip devices are not intended for quantitative results, nor for over the counter (OTC) sales. VicTorch hCG Test Strip devices are designed for professional use nor of of of over to over (viran analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.

The VicTorch hCG Test Strip device is a lateral flow qualitative color-conjugated immunochromatographic (CCI) in vitro diagnostic (IVD) assay for human Chorionic Gonadotropin (hCG) at the cutoff level of 20 mlU/ml of human urine, for detection of early pregnancy as commonly used by professionals. Measurements obtained by the qualitative VicTorch hCG Test Strips are used to aid in the diagnosis of pregnancy.