uTASWako AFP-L3 Calibrator Set

Basic Information

• Brand Name: uTASWako AFP-L3 Calibrator Set
• Primary DI: 00856626006168
• Version / Model: 997-60901
• Catalog Number: 997-60901
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Labeler DUNS: 690598875
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-25
• Public Version: 6
• Public Version Date: 2020-10-26
• Public Version Status: Update
• Public Device Record Key: 67d12573-9e50-4ad1-8f0a-e959aa7aae63
• 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: 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
45799	Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator	A material used to establish known points of reference for 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	00856626006168	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