FDA-IN VITRO DETECT Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi

FDA-IN VITRO DETECT - 2013 EDITION - CURRENT



Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi


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Document Number

FDA-IN VITRO DETECT

Revision Level

2013 EDITION

Status

Current

Publication Date

March 28, 2013

Page Count

12 pages