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DAVID One Step Home Use Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy. in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use. DAVID One Step Home Use Pregnancy Test Midstream is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for over-the-counter use only. DAVID One Step Prescription Pregnancy Test Strip is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use. DAVID One Step Prescription Pregnancy Test Cassette is an in-Vitro diagnostic test device for the qualitative detection of human chorionic gonadotropin (HCG) in the urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. This product is intended for prescription use.

DAVID One Step Pregnancy Test is designed in three formats: strip, cassette, and midstream. Each of the devices (strip, cassette and midstream) contains a pouch with the test device and instructions for use, additional test cassette also contains a disposable plastic dropper. The test cassette and test midstream consist of a chromatographic test strip enclosed in plastic housing. The test strip contains mouse monoclonal anti-ß-hCG antibody, mouse monoclonal anti-a-hCG antibody, goat anti-mouse IgG polyclonal antibody and colloidal gold. The added plastic housing does not affect the performance of the product, which is determined by the test strip. The only difference between the different formats is test procedure. The test uses two lines to indicate results. The appearance of two color bands, one at the "Test line" and one at the "Control line" region means the test is "positive". The appearance of a color band at the "Control line" region but not at the "Test line" region means the test is "negative". If there are no colored bands in the "Control line" area and "Test line" region or if there is no color band in "Control line" region even there is a band in the "Test line" region; this means "invalid" test result.

David Home Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for the Over-the-Counter Use only. David Professional Pregnancy Test Cassette is an in-vitro diagnostic test for the qualitative determination of human chorionic gonadotropin (HCG) in the urine to aid in early detection of pregnancy, based on lateral flow immunoassay. It is intended for prescription use only.

David Pregnancy Test Cassette will be designed in one format:Cassette.The Cassette kit consists of one test device, a disposable plastic dropper, and a package insert. Each test strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a pad containing mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG polyclonal antibody.