Get For In-vitro Diagnostic Use Only

For example, pipettes, test tubes, baths, centrifuges, balances and general consumables which are not specifically intended by the manufacturer to be used to perform a particular test, are not considered IVD medical devices.

Pregnancy tests, COVID-19 tests, and HIV tests are examples of IVD products. Other examples of IVD devices include: Cancer diagnostics.

The main difference is in the IVD space where clinical samples used may be excess samples from a clinical investigation or acquired by different clinical investigations. If these samples are used, the informed consent process and ethics committee approvals must be appropriate before these samples can be used.

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

There are three types of in-vitro diagnostic reagents used that include chemical, bio-chemical and immune-chemical. Chemical reagent is the basic IVD reagent used which incorporates dyes, surfactants, buffers, and basic chemicals.

The main difference is in the IVD space where clinical samples used may be excess samples from a clinical investigation or acquired by different clinical investigations. If these samples are used, the informed consent process and ethics committee approvals must be appropriate before these samples can be used.

There are 2 main types of IVD devices – laboratory-based tests and point-of-care tests.

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.