Collections: Health Policy and Services Research / Subjects: Reagent Kits, Diagnostic and United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

Start Over Collections Health Policy and Services Research ✖ Subjects Reagent Kits, Diagnostic ✖ Subjects United States. Department of Health and Human Services. ✖

1. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):: Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Testing for biotin interference in in vitro diagnostic devices

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2020
Subject(s):: Avidin -- antagonists & inhibitors
Biotin -- antagonists & inhibitors
Reagent Kits, Diagnostic
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.

4. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):: Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.