Product code PGH— Microbiology

“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.”

FDA has cleared 3 devices under product code PGH between 2014 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20142 clearances

• Focus Diagnostics2 clearances
• Midiagnostics NV1 clearance

• K250050 — miDiagnostics HSV-1&2 CSF TestMidiagnostics NV·2025-09-30
• K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACKFocus Diagnostics·2014-07-01
• DEN130049 — SIMPLEXA HSV 1&2 DIRECTFocus Diagnostics·2014-03-21