Everly Health, Inc.

Everly Health, Inc. specializes in devices for home-based specimen collection. Their portfolio includes capillary blood collection sets for home use, as well as in-vitro diagnostic (IVD) specimen containers and kits for oral/respiratory tract, urine, and faecal samples. These devices are designed for self-collection outside clinical settings, ensuring safe and sterile sample gathering for diagnostic testing.

Everly Health, Inc. is based in the United States. Their devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA), which regulates medical devices to ensure safety, effectiveness, and compliance with U.S. health standards. The company’s products are subject to FDA oversight due to their classification and intended use.

Yes, Everly Health, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is used to track and identify medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. Listing in the UDI database is required for Class I and Class II devices in the U.S., which includes most of Everly Health’s products.

Everly Health, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional controls due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, ensuring appropriate regulatory oversight.

The primary purpose of Everly Health, Inc.’s specimen collection kits is to enable safe, sterile, and user-friendly self-collection of biological samples—such as blood, saliva, urine, or stool—outside clinical settings. These kits are designed for home use, making diagnostic testing more accessible by allowing individuals to collect samples independently before sending them for laboratory analysis.