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3. 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

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
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.

7. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, July 2020
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Enforcement policy for viral transport media during the coronavirus disease 2019 (COVID19) public health emergency (revised): guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 2021
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Outbreaks: protecting Americans from infectious diseases : 2013

Author(s):
Levi, Jeffrey, author
Segal, Laura M., author
Lieberman, Dara Alpert, author
St. Laurent, Rebecca, author
Publication:
Washington, DC : Trust for America's Health, December 2013
Subject(s):
Communicable Disease Control
Disease Outbreaks
Acquired Immunodeficiency Syndrome -- prevention & control
Bioterrorism
Budgets
Climate Change
Communicable Diseases, Emerging
Emergency Medical Services
Foodborne Diseases
Hepatitis, Viral, Human -- prevention & control
HIV Infections -- prevention & control
Immunization Programs -- legislation & jurisprudence
Influenza Vaccines
Mandatory Reporting
Papillomavirus Infections -- epidemiology
Papillomavirus Infections -- prevention & control
Papillomavirus Vaccines -- administration & dosage
Public Health -- economics
Specimen Handling
Tuberculosis -- prevention & control
Whooping Cough -- epidemiology
Humans
United States

10. Outbreaks: protecting Americans from infectious diseases : 2014

Author(s):
Levi, Jeffrey, author
Segal, Laura M., author
Lieberman, Dara Alpert, author
May, Kendra, author
St. Laurent, Rebecca, author
Publication:
Washington, DC : Trust for America's Health, December 2014
Subject(s):
Communicable Disease Control
Disease Outbreaks
Acquired Immunodeficiency Syndrome -- prevention & control
Bioterrorism
Budgets
Climate Change
Communicable Diseases, Emerging
Emergency Medical Services
Foodborne Diseases
Hepatitis, Viral, Human -- prevention & control
HIV Infections -- prevention & control
Immunization Programs -- legislation & jurisprudence
Influenza Vaccines
Mandatory Reporting
Papillomavirus Infections -- epidemiology
Papillomavirus Infections -- prevention & control
Papillomavirus Vaccines -- administration & dosage
Public Health -- economics
Specimen Handling
Tuberculosis -- prevention & control
Whooping Cough -- epidemiology
Humans
United States