Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff

Name: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: diagnostics,fda,guidances,in-vitro-diagnostic-devices,in-vitro-diagnostics,industry,influenza,ivd,ivd-devices,performance,viruses

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Pediatric Product Development

Published

July 14, 2011

Last updated

April 11, 2024

Description

Guidance document on evaluating performance characteristics of in vitro diagnostic devices for detecting and differentiating influenza viruses.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff

Updated on April 11, 2024

pdf (289.0KB)

URL: https://www.fda.gov/media/71519/download
Permalink: https://data.openrid.co/en/datasets/r/95c11142-b13b-4a04-a9fa-f154b220652b
MIME Type: application/pdf

Created on: July 14, 2011
Modified on: April 11, 2024

Size: 289.0KB

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff

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