small dense LDL Seiken

Basic Information

• Brand Name: small dense LDL Seiken
• Primary DI: 04987503562890
• Version / Model: 08834075190
• Catalog Number: 08834075190
• 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: b2fe712c-c95c-420f-8d95-abdc5f74e0e7

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	04987503562890	GS1

Premarket Submissions

Submission Number	Supplement Number
K161679	000