FDA.reportPublic FDA data

MagBio Genomics, Inc.

Primary DI
00850045030001
Brand
MagBio Genomics, Inc.
Company
Magbio Genomics, Inc.
Model
MagXtract Collection Tube
Catalog number
MXCT-100
Device description
Collect sample, lyse to extract RNA/DNA
Published
2022-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045030001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078654815
Device count
1
Kit
true
Lot or batch
true
Serial number
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
00850045030018Magbio Genomics, Inc.MagCTL Collection Tube (100 tubes)MXCT-1002026-03-27
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