PGH — Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel Class II

FDA Device Classification

Classification Details

Product Code
PGH
Device Class
Class II
Regulation Number
866.3307
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

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 the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250050midiagnosticsmiDiagnostics HSV-1&2 CSF TestSeptember 30, 2025
K141458focus diagnosticsSIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKJuly 1, 2014
DEN130049focus diagnosticsSIMPLEXA HSV 1&2 DIRECTMarch 21, 2014