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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 2019
Status: active
Page Count: 10

Document History

21 CFR PART 809
April 1, 2023
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
April 1, 2022
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
April 1, 2021
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
April 1, 2020
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
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...
21 CFR PART 809
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...
21 CFR PART 809
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...
21 CFR PART 809
April 1, 2015
IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
A description is not available for this item.
21 CFR PART 809
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...
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References

This document is referenced by:
DODD 6480.04 CE-01 - ARMED SERVICES BLOOD PROGRAM
Published by DODD on June 29, 2023
Purpose: In accordance with the authority in DoD Directive (DoDD) 5124.02, the Deputy Secretary of Defense approval of the May 27, 2014 Under Secretary of Defense for Personnel and Readiness...
This document is referenced by:
ISO 21474-1 - In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
Published by ISO on August 1, 2020
This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more...
This document is referenced by:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
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