FDA Product Code PGH: Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel
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.
Leading manufacturers include Midiagnostics NV.
FDA 510(k) Cleared Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel Devices (Product Code PGH)
About Product Code PGH - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PGH since 2014, with 2 receiving FDA clearance (average review time: 136 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PGH have taken an average of 263 days to reach a decision - up from 73 days historically. Manufacturers should account for longer review timelines in current project planning.
PGH devices are reviewed by the Microbiology panel. Browse all Microbiology devices →