Airscan, Inc.

Airscan, Inc. specializes in in vitro diagnostic (IVD) devices primarily focused on erythrocyte sedimentation rate (ESR) testing. Their product line includes ESR analysers, capillary blood collection tubes without additives, and ESR-specific control reagents. These controls are used to ensure accuracy and reliability in laboratory settings, helping validate ESR test results.

Airscan, Inc. is based in the United States, which means its devices are subject to FDA regulatory requirements. The FDA classifies their ESR-related devices under Class I (generally low-risk) and Class II (moderate-risk), requiring compliance with specific regulations to ensure safety and performance before they can be marketed.

Airscan, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry provides a standardized way to track and identify medical devices, ensuring transparency in the supply chain and aiding in post-market surveillance and compliance efforts.

The FDA classifies Airscan, Inc.’s ESR-related devices into two categories: Class I and Class II. Class I devices, like some ESR controls, are typically low-risk and subject to general controls, while Class II devices, such as ESR analysers, require additional performance standards to mitigate moderate risks and ensure safe and effective use in clinical settings.