AU

Basic Information

• Brand Name: AU
• Primary DI: 15099590012120
• Version / Model: B93009
• Company Name: BECKMAN COULTER IRELAND INC.
• Labeler DUNS: 985071975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-13
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: b0cf24b8-d07d-49a8-9da8-5ab20d106480

Device Description

HbA1c Advanced

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	862.1373	2
LCP	Assay, Glycosylated Hemoglobin	Hematology	864.7470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59090	Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) 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	15099590012120	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at 2 to 8 degrees celcius