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510(k) K192376

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack by Diasorin Molecular, LLC — Product Code PGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2019
Date Received
August 30, 2019
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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Other clearances for product code PGI

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  • K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (October 29, 2018)
  • K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (March 14, 2018)
  • K162451 — Solana HSV 1+2/VZV Assay (November 28, 2016)
  • K151906 — ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol (October 6, 2015)
  • K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control (July 17, 2015)
  • DEN140004 — QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (May 13, 2014)