small dense LDL Control Set

Basic Information

• Brand Name: small dense LDL Control Set
• Primary DI: 04987503563088
• Version / Model: 08834105190
• Catalog Number: 08834105190
• Company Name: DENKA COMPANY LIMITED
• Labeler DUNS: 694830238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-13
• Public Version: 1
• Public Version Date: 2020-10-21
• Public Version Status: New
• Public Device Record Key: eeadd4f8-45cc-40dc-bf2a-b0cd48ccc00c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41729	Low density lipoprotein (LDL) cholesterol IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987503563088	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from light.