510(k) K250050
- Device
- miDiagnostics HSV-1&2 CSF Test
- Applicant
- Midiagnostics NV
- 510(k) number
- K250050
- Product code
- PGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-30
- Date received
- 2025-01-10
- Regulation
- 866.3307
- Classification name
- Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Katrin Martens
- Address
- Gaston Geenslaan 1 Leuven BE 3001 3001
FDA Registration Numbers#
- 2023365