Analytical, Diagnostic and Therapeutic Techniques, and Equipment

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.

National Library of MedicineMedical Subject Headings2026

Structured Summary

Abstract

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.

MeSH Record

Classification

Broader headings

Related Concepts

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MeSH Record

Synonyms

4 entry terms
  • Approval, Diagnostic Test
  • Approvals, Diagnostic Test
  • Diagnostic Test Approvals
  • In Vitro Diagnostic Device Approval

MeSH Record

Aspects Covered

5 allowable subheadings

Indexed with the subheadings economics, history, legislation & jurisprudence, standards, trends.

MeSH Record

History Note

2010

MeSH Hierarchy

Tree Numbers

  1. E05.337.275.500
  2. N06.850w.210.275.500

MeSH Record

NLM Classification

WA 289

AMA Style

References

  1. National Library of Medicine. Diagnostic Test Approval. Medical Subject Headings (MeSH). 2026. Unique ID D057069. http://id.nlm.nih.gov/mesh/2026/D057069
  2. Diagnostic Test Approval. In: Wikidata. https://www.wikidata.org/wiki/Q70439788