Subjects: In Vitro Techniques -- standards - Digital Collections - National Library of Medicine Search Results

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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. 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.