L-Type HDL-C Reagent 1

Basic Information

• Brand Name: L-Type HDL-C Reagent 1
• Primary DI: 10856626006196
• Version / Model: 997-72591
• Catalog Number: 997-72591
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-11-23
• Public Version: 6
• Public Version Date: 2022-03-08
• Public Version Status: Update
• Public Device Record Key: 184f9652-784e-4c65-922a-7c7343c2150d
• Distribution End Date: 2020-10-23

Device Description

In-Vitro Diagnostic Use

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	862.1475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44696	High density lipoprotein (HDL) cholesterol 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 high density lipoprotein (HDL) cholesterol lipid in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856626006196	GS1
Unit of Use	00856626006199	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K963847	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 2-10C. Do not freeze.