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The hCG One Step Pregnancy Test Strip Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use. The hCG One Step Pregnancy Test Midstream Rx is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For prescription use. The hCG One Step Pregnancy Test Strip OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use. The hCG One Step Pregnancy Test Midstream OTC is intended for qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. For in Vitro Diagnostic Use Only. For over-the-counter use.

The tests are rapid, one-step lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (HCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The assay is conducted by added urine sample and obtaining the result from the colored lines. The tests will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic card, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum foil pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum foil pouch, Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.