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FDA 510(k)

miDiagnostics HSV-1&2 CSF Test

K-Number: K250050 · 2025-09-30

ApplicantMidiagnostics NV
Decision Date2025-09-30
Product CodePGH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

miDiagnostics HSV-1&2 CSF Test is a medical device manufactured by Midiagnostics NV. It received FDA 510(k) clearance on 2025-09-30 under approval number K250050. The device is classified under product code PGH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the miDiagnostics HSV-1&2 CSF Test?

miDiagnostics HSV-1&2 CSF Test is a medical device that received FDA 510(k) clearance on 2025-09-30. It is manufactured by Midiagnostics NV. The 510(k) number is K250050.

When was miDiagnostics HSV-1&2 CSF Test approved by the FDA?

miDiagnostics HSV-1&2 CSF Test received FDA 510(k) clearance on 2025-09-30, under approval number K250050.

What company makes miDiagnostics HSV-1&2 CSF Test?

miDiagnostics HSV-1&2 CSF Test is manufactured by Midiagnostics NV.

What is the FDA product code for miDiagnostics HSV-1&2 CSF Test?

The FDA product code for miDiagnostics HSV-1&2 CSF Test is PGH.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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