BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 00847865011075
• Version / Model: SW4.1_1
• Catalog Number: 6651665E
• 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: 2020-01-23
• Public Version Status: Update
• Public Device Record Key: cc589741-55ac-48b8-907b-d8497c15a394

Device Description

U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1

Device Characteristics

• Single Use: No
• 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
OMI	Multiplex flow immunoassay, t.Gondii, rubella and cmv.	Microbiology	866.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50266	Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using a fluorescent immunoassay method.	No	Active
52437	Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen, using a fluorescent immunoassay method.	No	Active
49714	Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865011075	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Each