Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

DiaSorin Molecular LLC

The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Vzv Swab Direct, Simplexa Vzv Positive Control Pack.

Pre-market Notification Details

Device IDK192376
510k NumberK192376
Device Name:Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
ClassificationHerpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Applicant DiaSorin Molecular LLC 11331 Valley View Street Cypress,  CA  90630
ContactSharon Young
CorrespondentSharon Young
DiaSorin Molecular LLC 11331 Valley View Street Cypress,  CA  90630
Product CodePGI  
CFR Regulation Number866.3309 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-30
Decision Date2019-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101025712 K192376 000

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