Simplexa VZV Direct, Simplexa VZV Positive Control Pack

Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System

DiaSorin Molecular LLC

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

Pre-market Notification Details

Device IDK190219
510k NumberK190219
Device Name:Simplexa VZV Direct, Simplexa VZV Positive Control Pack
ClassificationMeningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
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 CodePLO  
CFR Regulation Number866.3970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-04
Decision Date2019-05-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101025781 K190219 000
20816101025774 K190219 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.