Autokit Micro Albumin Calibrator Set

Basic Information

• Brand Name: Autokit Micro Albumin Calibrator Set
• Primary DI: 04987481164529
• Version / Model: 995-06101
• Catalog Number: 995-06101
• 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: 9bb6fcb3-dbf8-4e85-aefc-90cc92d3a5ec

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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53477	Microalbumin IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987481164529	GS1
Previous	00856626006106	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030320	000

Storage Conditions

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