Simplexa Congenital CMV Direct And Simplexa Congenital CMV Positive Control Pack

Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection

DiaSorin Molecular LLC

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

Pre-market Notification Details

Device IDK202755
510k NumberK202755
Device Name:Simplexa Congenital CMV Direct And Simplexa Congenital CMV Positive Control Pack
ClassificationQualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
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 CodeQDZ  
CFR Regulation Number866.3181 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2022-11-05

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