510(k) K173798

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack by Diasorin Molecular, LLC — Product Code PGI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 14, 2018
Date Received: December 14, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class: Class II
Regulation Number: 866.3309
Review Panel: MI
Submission Type

For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.

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K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 2018)
K162451 — Solana HSV 1+2/VZV Assay (November 28, 2016)
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DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)