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The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy.

The modified device is substantially equivalent to the previously cleared Selfcare Predicate Device Early Pregnancy Test (K960436). The primary modifications are changes to the strip width and specimen sample size. Corresponding dimensional changes have been made to the housing to accommodate the narrower strip design. The modified device has the same technological characteristics as the legally marketed predicate device employing monoclonal antibodies for immunochromatographic assay.

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for Borrelia burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with Borrelia burgdorferi, the causative agent of Lyme Disease. The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kil can be used at any time following onset of symptoms provided the EIA or IFA is positive or equivocal. It should be used for follow up when: 1) Only IgM antibodies were originally detected, 2) IgG antibodies were detected but were not considered significant by Western blot, or 3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA tests.

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The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. II is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B.burgdorferi, the causative agent of Lyme disease. l he Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorfen IgM Western Blol kil can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not rocommended for use in determining aclive disease in persons with illness of longer than one month.

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