MagBio Genomics, Inc.

Basic Information

• Brand Name: MagBio Genomics, Inc.
• Primary DI: 00850045030490
• Version / Model: HighPrep™ DTR Clean-up System
• Catalog Number: DT-70250
• Company Name: Magbio Genomics, Inc.
• Labeler DUNS: 078654815
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-13
• Public Version: 1
• Public Version Date: 2022-09-21
• Public Version Status: New
• Public Device Record Key: eab2fb48-4acc-4b6d-9e2b-29de9f940bde

Device Description

Sanger sequencing reaction clean-up / dye terminator removal

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
62604	Nucleic acid library construction kit IVD	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850045030490	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]