What is IVD? What are the in vitro diagnostic devices?

release time:2021-07-26 15:11:59

1. What is in vitro diagnostic?

IVD (in vitro diagnosis) refers to the products and services outside the human body to obtain clinical diagnosis information by testing human samples (blood, body fluid, tissue, etc.), so as to judge diseases or body functions, so as to maintain the first market share in the medical device industry.

2. In vitro diagnostic devices

IVD contains two parts: instrument and reagent. The instrument belongs to the clinical inspection and analysis instrument under the classification of medical devices, and the reagent belongs to the major category of biological products in the biological medicine.

Common in vitro diagnostic devices:

Clinical chemistry assays
Immunoassays
Blood glucose monitors
Cancer diagnostics
Devices for the detection of infectious agents
Companion diagnostics
Devices for blood grouping
Devices for human genetic testing
Devices for tissue typing
PCR assays including next generation sequencing panels
Self-tests and near-patient testing devices
......

Reagents, reagent products, calibrators, control materials, kits, instruments, instruments, equipment, software or systems of any medical device, whether used alone or in combination, are intended to be used by the manufacturer in vitro to examine human-derived The samples, including blood and tissue donations, are all in vitro diagnostic medical devices.

3. How is IVD classified?

According to the detection category, it can be divided into blood test, biochemical diagnosis, immunodiagnosis, molecular diagnosis, microbiological diagnosis, POCT, etc.

in vitro diagnostic

The FDA classifies medical devices (including IVD products) into Class I, Class II, or Class III based on the level of regulatory control required to reasonably ensure safety and effectiveness. The classification of IVD (or other medical devices) determines the appropriate pre-marketing process.

4. What is POCT?

When it comes to IVD, one has to mention the popular industry of POCT. Point of care test is an emerging industry, which refers to the inspection of any medical measures required at the patient's medical field. The ultimate goal of POCT is to obtain reliable diagnosis results quickly and instantly.

The overall IVD market is dominated by biochemistry and immunology. In the past two years, affected by the epidemic, the molecular field is also very hot.

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