BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 00847865010900
• Version / Model: 6632320
• Catalog Number: 6632320
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: b2b3522b-436a-4269-ad6c-c1229c84eeb9

Device Description

Celiac IgA Calibrator Lot Data

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54814	Multiple Coeliac disease-associated antibody IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865010900	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Each