Formats: Text / Collections: Health Policy and Services Research / Subjects: United States. Food and Drug Administration. and Clinical Laboratory Techniques / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Formats Text ✖ Collections Health Policy and Services Research ✖ Subjects United States. Food and Drug Administration. ✖ Subjects Clinical Laboratory Techniques ✖ Genre Technical Report ✖

1. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 11, 2020
Subject(s):: Clinical Laboratory Techniques
COVID-19 Serological Testing
COVID-19 Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):: Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.