Diagnostic Test Approval [schvalování diagnostických testů]

topical
3
Terms

diagnostické testy - schvalování
in vitro diagnostické prostředky - schvalování

 

In Vitro Diagnostic Device Approval

Persistent link   https://www.medvik.cz/link/D057069
Definition

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.

DUI
D057069 MeSH Browser
CUI
M0534190
History note
2010
Public note
2010

Allowable subheadings

EC
economics
HI
history
LJ
legislation & jurisprudence
ST
standards 2
TD
trends

E Analytical, Diagnostic and Therapeutic Techniques and Equipment
E05 Investigative Techniques 209
E05.337 Evaluation Studies as Topic 1 233
E05.337.275 Device Approval 264
E05.337.275.500 Diagnostic Test Approval 3

N Health Care
N06 Environment and Public Health 203
N06.850 Public Health 4 047
N06.850.210 Consumer Product Safety 151
N06.850.210.275 Device Approval 264
N06.850.210.275.500 Diagnostic Test Approval 3

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