L-Type LDL-C Reagent 1

Basic Information

• Brand Name: L-Type LDL-C Reagent 1
• Primary DI: 14987481164533
• Version / Model: 999-00404
• Catalog Number: 999-00404
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: 74cf9f32-b3cd-49ce-ae11-a4c915cff38b

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
53398	Low density lipoprotein (LDL) cholesterol IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
Unit of Use	04987481164536	GS1
Primary	14987481164533	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982271	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius