uTASWako AFP-L3 Sample Dilution Buffer

Basic Information

• Brand Name: uTASWako AFP-L3 Sample Dilution Buffer
• Primary DI: 10856626006189
• Version / Model: 997-61501
• Catalog Number: 997-61501
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-12-22
• Public Version: 6
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 65b851f1-6e77-4b88-afd2-dbc81837227c
• 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
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	Immunology	866.6030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47211	Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of hepatocellular carcinoma (HCC).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856626006189	GS1
Unit of Use	00856626006182	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