uTASWako AFP-L3 Control L

Basic Information

• Brand Name: uTASWako AFP-L3 Control L
• Primary DI: 10856626006172
• Version / Model: 997-61001
• Catalog Number: 997-61001
• 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: 2016-11-25
• Public Version: 5
• Public Version Date: 2020-10-26
• Public Version Status: Update
• Public Device Record Key: f05f4d60-cf78-4727-ab75-31a5701ed690
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45800	Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control	A material used to verify the performance of an assay intended to qualitatively and/or quantitatively detect alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856626006172	GS1
Unit of Use	00856626006175	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