# Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/establishing-the-performance-characteristics-of-in-vitro-diagnostic-devices-for-the-detection-of-antibodies-to-borrelia-burgdorferi-guidance-for-industry-and-fda-staff/c9b388c4-7a07-4b67-9776-be87a6cfe611

> FDA guidance document: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff. Issue date: March 27, 2013. Get complete insights and analysis.

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## Details

- Title: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2013-03-27
- Last Changed: 2020-02-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0095">FDA-2008-D-0095</a>

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