Microalbumin

Basic Information

• Brand Name: Microalbumin
• Primary DI: 00628063401116
• Version / Model: SK252-20
• Catalog Number: SK252-20
• Company Name: SEKISUI DIAGNOSTICS, LLC
• Labeler DUNS: 966812344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-02
• Public Version: 1
• Public Version Date: 2019-10-10
• Public Version Status: New
• Public Device Record Key: 8b137e01-43ad-4f4b-9cd3-8915bb2a649a

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
DCF	ALBUMIN, ANTIGEN, ANTISERUM, CONTROL	Immunology	866.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53475	Microalbumin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628063401116	GS1

Premarket Submissions

Submission Number	Supplement Number
K051191	000