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Sanguina’s AnemoCheck Home obtains FDA clearance

AnemoCheck Home is the only FDA-cleared home anemia test with instant results.

Biotech company Sanguina has received the Food and Drug Administration’s clearance for AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.

Designed to empower individuals with anemia due to nutritional deficiency (iron deficiency anemia, vitamin B12 deficiency anemia and folate deficiency anemia), sickle cell disease and thalassemia, AnemoCheck Home allows users to monitor their hemoglobin levels in the comfort of their own homes. The test is an in vitro diagnostic device and will be available by prescription only, ensuring appropriate medical oversight and guidance.

Anemia, a condition marked by a shortage of healthy red blood cells or hemoglobin, affects more than 1.92 billion individuals worldwide. Acknowledging the pressing need for accessible and reliable testing, AnemoCheck Home detects and monitors anemia for those who need it most.

[Read more: The transformative potential of at-home diagnostics for retail pharmacies]

AnemoCheck Home allows users to obtain accurate hemoglobin level readings. The user performs a finger stick, collects blood into a sample collection tube and connects the test cap with a test body. The user then shakes the test to mix the blood. After 2 minutes, the color correlates to a hemoglobin level on a color card. The test is disposable and does not require any additional equipment.

Erika Tyburski, CEO of Sanguina said, "Our team at Sanguina is proud to introduce AnemoCheck Home as a game-changer for at-home anemia testing. With this FDA clearance, we are excited to provide people who have anemia with a convenient, accurate, and accessible tool to monitor their hemoglobin levels at home.”

Sanguina said AnemoCheck Home leverages the latest advancements in healthcare technology, ensuring reliable and precise results. The kit includes user-friendly instructions, and everything needed to perform the fingerstick test safely and efficiently.

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