FDA.reportPublic FDA data

MagBio Genomics, Inc.

Primary DI
00850045030032
Brand
MagBio Genomics, Inc.
Company
Magbio Genomics, Inc.
Model
MagBio CTL Medium MAX (500 mL)
Catalog number
MCTL-M500
Device description
Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
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#

Product Codes#

Code, Name table
CodeName
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045030032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045030032008500450300328500450300320850045030032

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078654815
Device count
1
Premarket exempt
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380211218Aero-MedAERO-MED, LLCNNL2026-03-20
50885380211216Aero-MedAERO-MED, LLCNNL2026-03-20
10850074089053ClinicoLabSurgyco LLCNNL2025-09-10
08800080220020ACS Combo-B IncubatorBSL Co.,LtdNNL2025-05-07
08800080220068ACS Combo-B IncubatorBSL Co.,LtdNNL2023-05-11
04038917085403Cool transport containerSarstedt Aktiengesellschaft & Co.KGNNL2022-11-30
00850045030025MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030049MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030056MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850040712018Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712032Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712063Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712070Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712001Mawi Dna TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712015Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712025Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712039Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712049Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712056Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712060Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712077Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10885380170805CARDINAL HEALTHCardinal Health 200, LLCNNL2020-05-30
10885380169618CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380169625CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380168833CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168840CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168871CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168888CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20