510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250050Substantially Equivalent

miDiagnostics HSV-1&2 CSF Test

Midiagnostics NV, Leuven, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250050 is the FDA 510(k) clearance record for miDiagnostics HSV-1&2 CSF Test, a class II device, cleared for Midiagnostics NV on under FDA product code PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel). FDA's definition for product code PGH reads: "Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in...". FDA records list one 510(k) clearance for Midiagnostics NV. As of , FDA records show no recalls naming K250050.

Clearance record

Decision date
Received
(263 days to decision)
Product code
PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Regulation
21 CFR 866.3307
Device class
Class II
Review panel
Microbiology
Applicant
Midiagnostics NV Gaston Geenslaan 1, Leuven, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGH

Trailing 12 months

FDA records hold no clearances under product code PGH in the trailing twelve months.

FDA records show no clearances under product code PGH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260