Tina-quant ß2-Microglobulin

Basic Information

• Brand Name: Tina-quant ß2-Microglobulin
• Primary DI: 07613336119990
• Version / Model: 08047430190
• Catalog Number: 08047430190
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 3
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 0b54ee53-c9fa-47d0-a219-3790301b91ac
• Distribution End Date: 2019-03-26

Device Characteristics

• Single Use: Yes
• 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: 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
53927	Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry	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 a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336119990	GS1

Storage Conditions

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