small dense LDL Seiken

Basic Information

• Brand Name: small dense LDL Seiken
• Primary DI: 04987503562883
• Version / Model: 08834059190
• Catalog Number: 08834059190
• 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: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: b5f389ce-d1cf-4329-9746-143c175416ae

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: 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
PYP	Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53395	Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of low density lipoprotein (LDL) cholesterol lipid in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987503562883	GS1

Premarket Submissions

Submission Number	Supplement Number
K161679	000

Storage Conditions

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