Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff

Name: Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff
Creator: Food and Drug Administration
Keywords: assessment,criteria,fda,guidances,industry,protein,review

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Postmarket

Published

September 22, 2005

Last updated

March 19, 2020

Description

This document is a guidance for industry and FDA staff on the review criteria for assessing CRP, hsCRP, and cardiac CRP assays.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff

Updated on March 19, 2020

pdf (175.8KB)

URL: https://www.fda.gov/media/71337/download
Permalink: https://data.openrid.co/en/datasets/r/e250899b-d45b-4742-b109-1595eb6eb675
MIME Type: application/pdf

Created on: September 22, 2005
Modified on: March 19, 2020

Size: 175.8KB

Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff

Information

Type

Regulated products

Topics

Published

Last updated

Description

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Country / Region

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