RF Titer Control

Basic Information

• Brand Name: RF Titer Control
• Primary DI: 08426950590477
• Version / Model: 300021062
• Company Name: BIOKIT, S.A.
• Labeler DUNS: 460055742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bc9eaf40-9994-4347-8bb3-8f1713860d0f

Device Description

2 x 1 ml titrated control

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
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	08426950590477	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K904310	000

Storage Conditions

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