EMAG®

Basic Information

• Brand Name: EMAG®
• Primary DI: 03573026471859
• Version / Model: 418591
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-26
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 092e439c-434e-44a9-9a70-7dea8b21a2e8

Device Description

The eMAG platform is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJH	CLINICAL SAMPLE CONCENTRATOR	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60736	Nucleic acid sample preparation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026471859	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 50 Degrees Celsius