In vitro diagnostic products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health in order to cure, mitigate, treat, or prevent disease or it sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
US 510(k) Cleared
Health Canada Licensed
CE marked
US Class I
Abbreviations
IVD: In-Vitro Diagnostic Use.
510(k): 510(k) Cleared. Cleared as a medical device by the US Food and Drug Administration for in vitro diagnostic use in the United States.
HCL: Health Canada Licensed
CE: CE marked product for IVD use.
US Class I: IVD product exempt from 510(k) requirements.
RUO: For Research Use Only.