Simplexa GBS Direct, Simplexa GBS Positive Control Pack

Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

DiaSorin Molecular LLC

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

Pre-market Notification Details

Device IDK182467
510k NumberK182467
Device Name:Simplexa GBS Direct, Simplexa GBS Positive Control Pack
ClassificationNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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 CodeNJR  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-10
Decision Date2018-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101025651 K182467 000
20816101025644 K182467 000

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