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The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.

The device is a kit containing the materials necessary to self-collect and test a capillary blood sample using a single-use, disposable unit. The test unit is a self-contained plastic housing for a nitrocellulose-based test strip, which employs the principals of blood cell separation. The plasma that is obtained during blood separation migrates through the test strip, and the migration front is made visible by staining with an impregnated dye. The plasma migration distance is linearly and inversely proportional to hemoglobin concentration. The kit is comprised of a blood testing unit packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, and collection instructions containing information about anemia.

The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

The device is a kit containing the materials necessary to self-collect a capillary blood sample onto a filter paper card for transport to a certified clinical laboratory for lipid profile testing. The kit is comprised of a blood collection card packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, collection instructions, return prepaid envelope, and a patient test authorization form.

The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

The device is a kit containing the materials necessary to collect a capillary blood sample onto a filter paper card for transport to a certified clinical laboratory for lipid profile testing. The kit is comprised of a blood collection card packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, collection instructions, return prepaid envelope, and a patient test authorization form.

The Safe At Home Test Kit for Monitoring Hemoglobin A1c is intended for home-use or office-use for collection and qualitative determination of hemoglobin A1c in dried whole blood. The product will be marketed over-the-counter. The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.

The device is a kit containing the materials necessary to collect a whole blood sample on a filter paper card and return the card by mail to the laboratory for determination of hemoglobin A1c. The kit comprises of a filter paper card in a resealable shipping bag containing a desiccant pouch, alcohol prep pad, disposable lancets, bandage strip instruction booklet, a return envelope, and a patient test authorization form.