BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 00847865002813
• Version / Model: 6600000
• Catalog Number: 6600000
• 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: 5
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: dfe2023f-e5d0-4843-ade8-e4a4354e5fb8

Device Description

BioPlex 2200 Instrument

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
NSU	Instrumentation for clinical multiplex test systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56726	Multiplex analyser IVD, laboratory, automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software. It operates with minimal technician involvement and complete automation of all procedural steps.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865002813	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BK140112	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Each

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity