Freelite® Human Kappa Free Kit for use on the Roche cobas® systems – Bulk kit

Basic Information

• Brand Name: Freelite® Human Kappa Free Kit for use on the Roche cobas® systems – Bulk kit
• Primary DI: 05051700016063
• Version / Model: LK016.10CB
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-08-04
• Public Version Status: Update
• Public Device Record Key: e1d223c5-f2b1-4733-bfd2-6f1b76afeab1
• Distribution End Date: 2023-06-30

Device Characteristics

• Single Use: No
• 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
DFH	Kappa, Antigen, Antiserum, Control	Immunology	866.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53799	Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins 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	05051700016063	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040009	000

Storage Conditions

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