Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff

Name: Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: diagnostics,fda,guidances,in-vitro-diagnostic-devices,in-vitro-diagnostics,industry,ivd,ivd-devices,migration,pre-market

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Premarket

Published

April 25, 2013

Last updated

February 28, 2020

Description

This document is a guidance for industry and FDA staff on assay migration studies for in vitro diagnostic devices in the premarket stage.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff

Updated on February 28, 2020

pdf (1.2MB)

URL: https://www.fda.gov/media/73669/download
Permalink: https://data.openrid.co/en/datasets/r/4589534a-90c4-4000-9ea0-1ecd0cd3f8c7
MIME Type: application/pdf

Created on: April 25, 2013
Modified on: February 28, 2020

Size: 1.2MB

Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff

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Regulated products

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