What is an in vitro diagnostic product (IVD)?
In vitro diagnostics product can be any reagents, instruments, and systems which are designed to diagnose disease or other conditions along with the state of health. It helps in providing good cure, treatment and help in prevention against diseases. These products are designed by leading manufacturers like Hologic, Abbott etc. present at www.ilexmedical.com. Such products are used in the accumulation, research and examination of specimens drawn from the human body.
Definition: 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 its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3] Regulatory Authority: IVDs are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.
