In Vitro Diagnosis(IVD) is generally performed in an artificial environment, rather than in a living body. IVD can be performed in laboratories, healthcare facilities, and even at home. These diagnostic tests can be performed on a variety of instruments, from small hand-held tests to complex laboratory instruments. IVD medical products include: reagents, reagent products, calibration materials, control materials, kits, instruments, equipment and systems, which are used to diagnose diseases, monitor individual health and examine human specimens (tissues, blood, urine, etc.) in the treatment processes.
IVD reagents definition: These reagents are tests for in-vitro diagnostics that can be used for: hepatitis or HIV testing, clinical chemistry, coagulation test systems, urine test strips, pregnancy tests, blood glucose monitoring systems for diabetic patients, medical specimen containers.
Accessories of IVD products are not in the category of IVD medical equipment, which are only used in conjunction with the IVD products examples. In fact, accessories are regarded as independent IVD medical products. Common accessories of IVD products include self-checking devices and products for performance evaluation.
1) Self-checking device. The self-checking devices constitute a special collection of IVD equipment. For example, some test tube baby detectors can be used by ordinary people in the home environment for pregnancy testing.
2) Products used for performance evaluation. Research equipment for performance evaluation which is not used for testing must also meet the relevant requirements of IVD products. However, IVD products used only for veterinary drugs and products for general laboratory use are not subject to relevant restrictions.