VARIANT II

Basic Information

• Brand Name: VARIANT II
• Primary DI: 00847817014949
• Version / Model: 2702000
• Catalog Number: 2702000
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 132528295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-31
• Public Version: 1
• Public Version Date: 2023-02-08
• Public Version Status: New
• Public Device Record Key: 3991697c-41d6-4130-b448-af0db35d3963

Device Description

VARIANT II

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDM	INSTRUMENTATION, HIGH PRESSURE LIQUID CHROMATOGRAPHY	Clinical Chemistry	862.2260	1

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	00847817014949	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 each