BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 03610520506417
• Version / Model: 12000878
• Catalog Number: 12000878
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-30
• Public Version: 1
• Public Version Date: 2019-05-08
• Public Version Status: New
• Public Device Record Key: b0eeaed8-ba76-41b9-ab44-1370fe79dd67

Device Description

BioPlex 2200 Lyme Total Calibrator CD

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
JIT	Calibrator, secondary	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50569	Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, calibrator	A material used to establish known points of reference for an assay intended for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610520506417	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183446	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Each