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In vitro diaqnostik məhsul (IVD) nədir?

Vaxt: 2024-02-29 Oxunub: 29

Tanım: 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.

Regulatory Authority: IVDs are cihazlar as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be bioloji məhsullar subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.

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