PGH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3307
- Medical specialty
- Microbiology
- Flags
- Life-sustaining
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| miDiagnostics HSV-1&2 CSF Test (K250050) | Midiagnostics NV | 2025-09-30 |
| SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (K141458) | Focus Diagnostics | 2014-07-01 |
| SIMPLEXA HSV 1&2 DIRECT (DEN130049) | Focus Diagnostics | 2014-03-21 |
Track PGH automatically
Every clearance here is in the API, with alerts when new ones post.