K-number	K250050
Device name	miDiagnostics HSV-1&2 CSF Test
Applicant	Midiagnostics NV
Product code	PGH
Device class	Class II
Decision date	Sep 30, 2025
Decision	Substantially Equivalent
Regulation	866.3307

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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miDiagnostics HSV-1&2 CSF Test

Everything you need for a 510(k) submission. Nothing you don't.