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HHS - 21 CFR PART 809

IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

active, Most Current
Organization: HHS
Publication Date: 1 April 2018
Status: active
Page Count: 10
scope:

Definitions.

In vitro diagnostic products are those reagents, instruments, and systems intended for use in the 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. These products are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act), and may also be biological products subject to section 351 of the Public Health Service Act.

A product class is all those products intended for use for a particular determination or for a related group of determinations or products with common or related characteristics or those intended for common or related uses. A class may be further divided into subclasses when appropriate.

[Reserved]

Act means the Federal Food, Drug, and Cosmetic Act.

Document History

April 1, 2019
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
April 1, 2018
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Definitions. In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of...
April 1, 2017
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of...
April 1, 2016
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of...
April 1, 2015
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
April 1, 2014
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
Definitions. (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of...

References

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