Boston Cell Standards, Inc.

Boston Cell Standards, Inc. specializes in in vitro diagnostic (IVD) controls. Specifically, their devices are designed as controls for human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) testing, primarily used in immunohistochemistry (IHC) workflows. These controls help laboratories validate and ensure the accuracy of diagnostic tests.

The company is based in the United States. This location is relevant for understanding regulatory frameworks, as their devices are developed and marketed in compliance with US medical device regulations.

Boston Cell Standards, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries help track and identify medical devices that have undergone regulatory review processes, such as the 510(k) clearance pathway for Class II devices.

The company’s devices are classified as Class II medical devices under US regulations. This classification typically indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.