What is an in vitro diagnostic device?
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.
What does IVD mean?
IVD
| Acronym | Definition |
|---|---|
| IVD | Ischemic Vascular Disease |
| IVD | Ion Vapor Deposition |
| IVD | Idiopathic Vestibular Disease |
| IVD | Intervertebral Disc Disease (canines) |
What does in vitro use mean?
In vitro is used to describe work that’s performed outside of a living organism. This can include studying cells in culture or methods of testing the antibiotic sensitivity of bacteria.
What is a Class 2 medical device?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
What is a medical IVD?
An IVD Medical Device is defined as a device which, whether used alone or in combination, is intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
What is Ivdd regulation?
The IVDD specifically addresses the safety, quality and performance of In Vitro Diagnostic medical devices (IVDs). The aim of the Directive is to ensure that IVDs do not compromise the health and safety of patients, users and third parties and attain the performance levels specified by the manufacturer.
How is in vitro testing done?
In vitro testing occurs in a laboratory and usually involves studying microorganisms or human or animal cells in culture. This methodology allows scientists to evaluate various biological phenomena in specific cells without the distractions and potential confounding variables present in whole organisms.