Glycated Serum Protein Calibrator Set

Basic Information

• Brand Name: Glycated Serum Protein Calibrator Set
• Primary DI: 00657498000854
• Version / Model: 2360-401
• Catalog Number: 2360-401
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: ba430cda-0e41-4b52-ad70-a07160e611a7
• Distribution End Date: 2022-08-30

Device Description

Stanbio Glycated Serum Protein (GSP) Calibrator Kit is intended to be used for calibration of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062).

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
JIT	Calibrator, Secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53275	Fructosamine 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 the glycated serum protein fructosamine in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498000854	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius