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Sanguina Obtains U.S. FDA Clearance for AnemoCheck Home

Thursday, October 05, 2023

Sanguina, Inc. (Sanguina), a prominent player in the biotechnology sector, is delighted to announce the FDA clearance for AnemoCheck Home. This marks the exclusive FDA-approved at-home hemoglobin test kit accessible in the United States. AnemoCheck Home represents an innovative solution, offering individuals the ability to monitor their hemoglobin levels in the convenience of their homes. This is particularly beneficial for those with anemia caused by nutritional deficiencies (such as iron deficiency anemia, vitamin B12 deficiency anemia, and folate deficiency anemia), sickle cell disease, and thalassemia. It's important to note that this test is classified as an in vitro diagnostic device and will be available solely by prescription, ensuring that users receive appropriate medical oversight and guidance.

Anemia, a condition characterized by a deficiency of healthy red blood cells or hemoglobin, affects more than 1.92 billion individuals worldwide. Recognizing the urgent need for accessible and reliable testing, AnemoCheck Home offers an innovative solution for detecting and monitoring anemia for those who need it most.

AnemoCheck Home allows users to obtain precise hemoglobin level readings through a simple fingerstick blood test. Users perform a fingerstick, collect a blood sample in a provided tube, and attach the test cap to a testing device. Following this, they shake the test to mix the blood, and after a brief 2-minute wait, the color corresponds to a hemoglobin level displayed on a color card. This test is designed for one-time use and does not require any additional equipment.

Erika Tyburski, CEO of Sanguina, expresses, "Our team at Sanguina is thrilled to introduce AnemoCheck Home as a groundbreaking solution for at-home anemia testing. With the FDA clearance in hand, we are enthusiastic about providing individuals with anemia a convenient, accurate, and readily accessible tool to monitor their hemoglobin levels in the comfort of their own homes."

AnemoCheck Home leverages the latest advancements in healthcare technology, ensuring dependable and precise results that empower users to take control of their anemia management. The kit includes user-friendly instructions and all the necessary components for safely and efficiently performing the fingerstick test.

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