Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
Information
Type
Guidance
Regulated products
IVDMD, Medical Devices
Topics
Premarket
Published
March 27, 2013
Last updated
February 28, 2020
Description
This document is a guidance for industry and FDA staff on establishing the performance characteristics of in vitro diagnostic devices for detecting antibodies to Borrelia burgdorferi.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)