Chemistry HbA1c Calibrator Kit

Basic Information

• Brand Name: Chemistry HbA1c Calibrator Kit
• Primary DI: 00386100001797
• Version / Model: 10658
• Catalog Number: 10658
• Company Name: MEDICA CORPORATION
• Labeler DUNS: 112942404
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-14
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 28e0eb28-aaba-4005-b118-930b7b2029e2

Device Description

HbA1c Calibrator Kit for use with EasyRA Analyzer

Device Characteristics

• Single Use: No
• 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: Yes
• 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
53315	Glycated haemoglobin (HbA1c) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00386100001797	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120497	000

Storage Conditions

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