FDA.reportPublic FDA data

Magbio Genomics, Inc.

Primary DI
00850045030018
Brand
Magbio Genomics, Inc.
Company
Magbio Genomics, Inc.
Model
MagCTL Collection Tube (100 tubes)
Catalog number
MXCT-100
Device description
Collect sample, lyse to extract RNA/DNA
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBDMicrobial Nucleic Acid Storage And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBDMicrobial Nucleic Acid Storage And Stabilization DeviceMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212113000MagXtract Collection TubeMagbio Genomics, Inc.2022-07-28QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045030018PackageGS1100In Commercial Distribution
00850045030001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045030018008500450300188500450300180850045030018
00850045030001008500450300018500450300010850045030001

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(301) 302-0144support@magbiogenomics.com

Regulatory Flags#

DUNS number
078654815
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850045030008Magbio Genomics, Inc.MagCTL Collection Tube (2500 tubes)MXCT-25002026-03-27
00850049735490Magbio Genomics, Inc.MagCTL Collection Tube (5 tubes)MXCT-52026-03-27
00850045030001MagBio Genomics, Inc. MagXtract Collection TubeMXCT-1002022-09-13
00850045030025MagBio Genomics, Inc. MagBio CTL Medium MAX (1000 mL)MCTL-M10002022-09-13
00850045030032MagBio Genomics, Inc. MagBio CTL Medium MAX (500 mL)MCTL-M5002022-09-13
00850045030049MagBio Genomics, Inc. MagBio CTL Medium VIRAL (1000 mL)MCTL-V10002022-09-13
00850045030056MagBio Genomics, Inc. MagBio CTL Medium VIRAL (500 mL)MCTL-V5002022-09-13
00850045030063MagBio Genomics, Inc. HighPrep™ Viral DNA/RNAHPV-DR962022-09-13
00850045030070MagBio Genomics, Inc. HighPrep™ Viral DNA/RNA HPV-DR96x42022-09-13
00850045030087MagBio Genomics, Inc. HighPrep™ Blood & Tissue DNAHPBTS-D962022-09-13
00850045030094MagBio Genomics, Inc. HighPrep™ Blood & Tissue DNAHPBTS-D96x42022-09-13
00850045030100MagBio Genomics, Inc. HighPrep™ FFPE DNAHPFF-D962022-09-13
00850045030117MagBio Genomics, Inc. HighPrep™ FFPE DNAHPFF-D96x42022-09-13
00850045030124MagBio Genomics, Inc. HighPrep™ PCRAC-600052022-09-13
00850045030131MagBio Genomics, Inc. HighPrep™ PCRAC-600502022-09-13
00850045030148MagBio Genomics, Inc. HighPrep™ PCRAC-602502022-09-13
00850045030155MagBio Genomics, Inc. HighPrep™ PCRAC-605002022-09-13
00850045030162MagBio Genomics, Inc. HighPrep™ Viral DNA/RNAHPV-DR38402022-09-13
00850045030179MagBio Genomics, Inc. HighPrep™ Plasmid DNA Plus HPPL-D962022-09-13
00850045030186MagBio Genomics, Inc. HighPrep™ Plasmid DNA PlusHPPL-D96x42022-09-13

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Primary DI, Brand, Company table
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10850045030008Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
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