BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 03610522004980
• Version / Model: 12006863
• Catalog Number: 12006863
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-05
• Public Version: 4
• Public Version Date: 2020-01-23
• Public Version Status: Update
• Public Device Record Key: 3fa36d5d-7833-4e68-b556-02d384a3aafe

Device Description

BioPlex 2200 Sample Dilution Buffer (1X), 120 mL

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GMQ	ANTIGENS, NONTREPONEMAL, ALL	Microbiology	866.3820	2
LIP	ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM	Microbiology	866.3830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610522004980	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	120	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius