RF Control Set

Basic Information

• Brand Name: RF Control Set
• Primary DI: 04015630916566
• Version / Model: 3005496122
• Catalog Number: 3005496122
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d1155ad2-8098-44c1-b77c-df3118ecdf1a

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: 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
DHR	SYSTEM, TEST, RHEUMATOID FACTOR	Immunology	866.5775	2

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	04015630916566	GS1

Premarket Submissions

Submission Number	Supplement Number
K002609	000

Storage Conditions

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