Binx Health Io CT/NG Assay

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Binx Health, Inc.

The following data is part of a premarket notification filed by Binx Health, Inc. with the FDA for Binx Health Io Ct/ng Assay.

Pre-market Notification Details

Device IDK191352
510k NumberK191352
Device Name:Binx Health Io CT/NG Assay
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant binx Health, Inc. 77 N. Washington Street, 5th Floor Boston,  MA  02114
ContactSarah Kalil
CorrespondentSarah Kalil
binx Health, Inc. 77 N. Washington Street, 5th Floor Boston,  MA  02114
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
Subsequent Product CodeNSU
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-20
Decision Date2019-08-08

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