MagXtract Collection Tube

Microbial Nucleic Acid Storage And Stabilization Device

MagBio Genomics, Inc.

The following data is part of a premarket notification filed by Magbio Genomics, Inc. with the FDA for Magxtract Collection Tube.

Pre-market Notification Details

Device IDK212113
510k NumberK212113
Device Name:MagXtract Collection Tube
ClassificationMicrobial Nucleic Acid Storage And Stabilization Device
Applicant MagBio Genomics, Inc. 944 Clopper Rd Gaithersburg,  MD  20878
ContactMothomang Mlalazi-Oyinloye
CorrespondentMukesh Kumar
Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown,  MD  20876
Product CodeQBD  
CFR Regulation Number866.2950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-07
Decision Date2022-07-28

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