RHEUMATEX®

Basic Information

• Brand Name: RHEUMATEX®
• Primary DI: 10859035006009
• Version / Model: 34S2
• Company Name: ALERE NORTH AMERICA, LLC
• Labeler DUNS: 826027364
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: eb00113a-ca0e-411f-8da6-f3d3cbabb46f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DHR	System, Test, Rheumatoid Factor	Immunology	866.5775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54846	Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrulline peptide.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10859035006009	GS1
Unit of Use	00859035006002	GS1

Customer Contacts

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

Storage Conditions

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