Lp(a) CAL SET

Basic Information

• Brand Name: Lp(a) CAL SET
• Primary DI: 05055273204438
• Version / Model: LP3404
• Catalog Number: LP3404
• Company Name: RANDOX LABORATORIES LIMITED
• Labeler DUNS: 227530649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d3655da4-41eb-449c-b9aa-66aece9a7521

Device Description

This product is intended for use in the calibration of Lipoprotein(a) assays.

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
JIS	Calibrator, Primary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41417	Lipoprotein A IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055273204438	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011568	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Once reconstituted, the Randox Lp(a) calibrator series is stable for 14 days at +2°C to +8°C in the absence of bacterial contamination.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius