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Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.). Office of In Vitro Diagnostics and Radiological Health, issuing body.
Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (41 pages)).
NLM Unique ID:
101713268 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101713268