Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff

Name: Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: diagnostics,fda,guidances,industry,molecular-diagnostics,pre-market

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Premarket

Published

November 12, 2014

Last updated

March 2, 2020

Description

A guidance document for industry and FDA staff on molecular diagnostic instruments with combined functions 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

Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff

Updated on March 2, 2020

pdf (424.7KB)

URL: https://www.fda.gov/media/85513/download
Permalink: https://data.openrid.co/en/datasets/r/1162b678-4b73-4bde-b8c0-fafe069e1be7
MIME Type: application/pdf

Created on: November 12, 2014
Modified on: March 2, 2020

Size: 424.7KB

Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Organization

Country / Region

License

Feedback

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