MagBio Genomics, Inc. MCTL-M500

GUDID 00850045030032

Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA

Magbio Genomics, Inc.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00850045030032
• NIH Device Record Key: caf37e2f-2d5c-48c7-a67a-c0e4b465896a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MagBio Genomics, Inc.
• Version Model Number: MagBio CTL Medium MAX (500 mL)
• Catalog Number: MCTL-M500
• Company DUNS: 078654815
• Company Name: Magbio Genomics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com
• Phone: (301) 302-0144
• Email: support@magbiogenomics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045030032 [Primary]

FDA Product Code

• NNL: Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-21
• Device Publish Date: 2022-09-13

On-Brand Devices [MagBio Genomics, Inc. ]

• 00850045030841: Isolation of nucleic acids from bacteria and human skin cells
• 00850045030834: Isolation of nucleic acids from bacteria and human skin cells
• 00850045030827: Isolation of nucleic acids from bacteria and human skin cells
• 00850045030810: Isolation of nucleic acids from bacteria and human skin cells
• 00850045030544: RNA and ss cDNA clean-up or concentration
• 00850045030537: RNA and ss cDNA clean-up or concentration
• 00850045030520: RNA and ss cDNA clean-up or concentration
• 00850045030513: RNA and ss cDNA clean-up or concentration
• 00850045030506: Sanger sequencing reaction clean-up / dye terminator removal
• 00850045030490: Sanger sequencing reaction clean-up / dye terminator removal
• 00850045030483: Sanger sequencing reaction clean-up / dye terminator removal
• 00850045030476: Sanger sequencing reaction clean-up / dye terminator removal
• 00850045030469: DNA quantitation and normalization of DNA concentration
• 00850045030452: DNA quantitation and normalization of DNA concentration
• 00850045030445: DNA quantitation and normalization of DNA concentration
• 00850045030391: Viral/Pathogen RNA and DNA isolation
• 00850045030384: Viral/Pathogen RNA and DNA isolation
• 00850045030377: Viral/Bacterial RNA and DNA isolation
• 00850045030360: Viral/Bacterial RNA and DNA isolation
• 00850045030353: Viral RNA isolation - KingFisher MVP II Alternative
• 00850045030346: Viral RNA isolation
• 00850045030339: cfDNA (ccfDNA) extraction
• 00850045030322: cfDNA (ccfDNA) extraction
• 00850045030315: cfDNA (ccfDNA) extraction
• 00850045030308: cfDNA (ccfDNA) stabilization and extraction
• 00850045030292: cfDNA (ccfDNA) stabilization and extraction
• 00850045030285: cfDNA (ccfDNA) stabilization and extraction
• 00850045030278: Genomic DNA isolation from 30 mg lysate of tissues or cultured cells
• 00850045030261: Genomic DNA isolation from 30 mg lysate of tissues or cultured cells
• 00850045030254: RNA isolation from tissues, cultured cells, and whole blood
• 00850045030247: RNA isolation from tissues, cultured cells, and whole blood
• 00850045030230: RNA isolation from tissues, cultured cells, and whole blood
• 00850045030193: Plasmid DNA isolation
• 00850045030186: Plasmid DNA isolation
• 00850045030179: Plasmid DNA isolation
• 00850045030162: Viral RNA and DNA isolation
• 00850045030155: Post-PCR and post-enzymatic reaction clean-up
• 00850045030148: Post-PCR and post-enzymatic reaction clean-up
• 00850045030131: Post-PCR and post-enzymatic reaction clean-up
• 00850045030124: Post-PCR and post-enzymatic reaction clean-up
• 00850045030117: Genomic DNA isolation from FFPE tissues
• 00850045030100: Genomic DNA isolation from FFPE tissues
• 00850045030094: Blood and tissue gDNA extraction
• 00850045030087: Blood and tissue gDNA extraction
• 00850045030070: Viral RNA and DNA isolation
• 00850045030063: Viral RNA and DNA isolation
• 00850045030056: Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
• 00850045030049: Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
• 00850045030032: Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA
• 00850045030025: Collection of pathogen sample, lysis, and transportation while ensuring stability of DNA and RNA