Diagnostic Test Approval

The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.

Year introduced: 2010

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Tree Number(s): E05.337.275.500, N06.850.210.275.500

MeSH Unique ID: D057069

Entry Terms:

• Approval, Diagnostic Test
• Approvals, Diagnostic Test
• Diagnostic Test Approvals
• In Vitro Diagnostic Device Approval

All MeSH Categories
Analytical, Diagnostic and Therapeutic Techniques and Equipment Category
Investigative Techniques
Evaluation Studies as Topic
Device Approval
Diagnostic Test Approval

All MeSH Categories
Health Care Category
Environment and Public Health
Public Health
Consumer Product Safety
Device Approval
Diagnostic Test Approval