uTASWako DCP Calibrator Set

Basic Information

• Brand Name: uTASWako DCP Calibrator Set
• Primary DI: 04987481164475
• Version / Model: 999-61201
• Catalog Number: 999-61201
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-23
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 9d89bb99-14d3-4ab4-9c49-b547e2594029

Device Description

In-Vitro Diagnostic Use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47213	Des-gamma-carboxyprothrombin (DCP) IVD, calibrator	A material used to establish known points of reference for an assay intended to qualitatively and/or quantitatively detect des-gamma-carboxyprothrombin (DCP) [protein induced by vitamin K absence-II (PIVKA-II)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987481164475	GS1
Previous	00856626006212	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100464	000

Storage Conditions

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