Beta-2 Microglobulin ELISA

Basic Information

• Brand Name: Beta-2 Microglobulin ELISA
• Primary DI: 00840239017895
• Version / Model: EIA-1789
• Catalog Number: EIA-1789
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-10
• Public Version: 4
• Public Version Date: 2023-08-16
• Public Version Status: Update
• Public Device Record Key: 7bc8810e-c9b1-4fd9-9b99-43e63cba7e5d

Device Description

The Beta-2 Microglobulin ELISA is intended for the quantitative determination of ß2-microglobulin in human serum.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JZG	System, test, beta-2-microglobulin immunological	Immunology	866.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53928	Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-2-microglobulin in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239017895	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius