RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV)

Basic Information

• Brand Name: RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV)
• Primary DI: 05055273216240
• Version / Model: LV10343
• Catalog Number: LV10343
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 1
• Public Version Date: 2020-01-30
• Public Version Status: New
• Public Device Record Key: b3dbc262-22fc-4c52-900d-dfd02d316c3b

Device Description

Rheumatoid Factor Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Rheumatoid Factor (RF).

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: 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42231	Rheumatoid factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273216240	GS1

Customer Contacts

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

Storage Conditions

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