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 the device name listed in this FDA 510(k) record. The listed applicant is Midiagnostics NV. It received FDA 510(k) clearance on 2025-09-30 under 510(k) 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. The listed applicant is Midiagnostics NV. The 510(k) number is K250050.
When did miDiagnostics HSV-1&2 CSF Test receive FDA 510(k) clearance?
miDiagnostics HSV-1&2 CSF Test received FDA 510(k) clearance on 2025-09-30, under 510(k) number K250050.
Who is the listed applicant for miDiagnostics HSV-1&2 CSF Test?
The FDA 510(k) record lists Midiagnostics NV as the applicant. This does not by itself establish the device manufacturer.
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.