FDA.reportPublic FDA data

MagBio Genomics, Inc.

Primary DI
00850045030155
Brand
MagBio Genomics, Inc.
Company
Magbio Genomics, Inc.
Model
HighPrep™ PCR
Catalog number
AC-60500
Device description
Post-PCR and post-enzymatic reaction clean-up
Published
2022-09-13
Public version status
New
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
00850045030155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045030155008500450301558500450301550850045030155

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid library construction kit IVDA collection of reagents and other associated materials intended to be used for the construction of fragmented nucleic acids [deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for use in genomic sequencing assays. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs) and is intended to be used for whole genome and/or complementary deoxyribonucleic acid (cDNA) library construction.

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
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
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