Revvity, Inc.

Revvity, Inc. specializes in in vitro diagnostic (IVD) devices, primarily dried blood spot collection cards like the Revvity GRNK1 Card. These cards are designed for collecting and storing blood samples for diagnostic testing. The company also produces the AutoDELFIA hAFP Test System, which measures human alpha-fetoprotein levels in clinical settings. These products are tailored for laboratory and diagnostic use.

Revvity, Inc. is headquartered in the United States. The devices it manufactures, including dried blood spot collection cards and diagnostic systems like the AutoDELFIA hAFP Test System, are intended for use within the U.S. regulatory environment, where they are subject to FDA oversight.

Revvity’s devices are listed under the FDA’s Premarket Approval (PMA) program for certain Class III products, as well as the Unique Device Identifier (UDI) program. These registries ensure traceability and compliance with U.S. regulatory requirements for medical devices, particularly those requiring rigorous pre-market evaluation or identification.

Revvity’s devices fall into two main regulatory classes: Class I and Class III. Class I devices generally pose minimal risk and may require less stringent controls, while Class III devices, such as some diagnostic systems, are higher risk and typically require premarket approval (PMA) due to their critical role in patient safety or effectiveness. Classification depends on factors like the device’s intended use and potential health impact.