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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
510(k) Number K250050
Device Name miDiagnostics HSV-1&2 CSF Test
Applicant
Midiagnostics NV
Gaston Geenslaan 1
Leuven,  BE 3001
Applicant Contact Katrin Martens
Correspondent
Midiagnostics NV
Gaston Geenslaan 1
Leuven,  BE 3001
Correspondent Contact Katrin Martens
Classification Product Code
PGH  
Subsequent Product Code
NSU  
Date Received01/10/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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