BioPlex 2200

Basic Information

• Brand Name: BioPlex 2200
• Primary DI: 03610521185987
• Version / Model: 4.3_v5
• Catalog Number: 12006557
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-27
• Public Version: 1
• Public Version Date: 2018-09-27
• Public Version Status: New
• Public Device Record Key: b77b3ba6-fa0d-4a83-a0aa-2d18b395ecb5

Device Description

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
MRG	SYSTEM, TEST, VITAMIN D	Clinical Chemistry	862.1825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60922	Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a chemiluminescent immunoassay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610521185987	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 Each