PGHClass IILife-sustaining

Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel

Microbiology · 21 CFR 866.3307

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.

MDR events1All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances3All time

Recent MDR events

1 adverse event reports on file

SIMPLEXA HSV 1 & 2 DIRECT KITMay 22, 2026
DeathDiasorin Molecular Llc2023365-2026-00001

Event type breakdown

Death1

Most-reported manufacturers

Diasorin Molecular Llc1

Recalls

1 recall events for this product code

Focus Diagnostics Inc
TerminatedApr 2, 2016
Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates.
Z-1272-2016 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Diasorin Molecular Llc
CYPRESS, CA, US

510(k) clearances

3 clearances for this product code