uTASWako DCP

Basic Information

• Brand Name: uTASWako DCP
• Primary DI: 04987481164413
• Version / Model: 995-60701
• Catalog Number: 995-60701
• 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: 1
• Public Version Date: 2020-11-02
• Public Version Status: New
• Public Device Record Key: 3cd316f9-b52e-4ff2-814b-e50e606b8c49

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
OAU	Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma	Immunology	866.6030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47216	Des-gamma-carboxyprothrombin (DCP) IVD, reagent	A biochemical agent intended to be used with a parent IVD to perform a specific function in an assay used 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	04987481164413	GS1
Previous	00856626006120	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