Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Premarket
Published
May 15, 1992
Last updated
March 17, 2020
Description
A guidance document outlining review criteria for premarket approval of in vitro diagnostic devices for detecting antibodies to Parvovirus B19.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)