HbA1c Calibrator Set

Basic Information

• Brand Name: HbA1c Calibrator Set
• Primary DI: 00812137012203
• Version / Model: 4 x 0.5mL
• Catalog Number: 502-189
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Labeler DUNS: 048144997
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d37a8d9e-545d-49c6-9a6a-ad445cb6c3bc

Device Description

This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
LCP	Assay, Glycosylated Hemoglobin	Hematology	864.7470	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	00812137012203	GS1
Unit of Use	00812137012456	GS1

Customer Contacts

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

Storage Conditions

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