BioPlex® 2200

Basic Information

• Brand Name: BioPlex® 2200
• Primary DI: 03610520506493
• Version / Model: 6633435
• Catalog Number: 6633435
• Company Name: BIO-RAD LABORATORIES, INC.
• Labeler DUNS: 884513334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-28
• Public Version: 6
• Public Version Date: 2021-07-29
• Public Version Status: Update
• Public Device Record Key: 2eecccc0-aa59-4f2b-9dbd-051ee4002aa8

Device Description

BioPlex 2200, HIV Ag-Ab Control Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
MZF	Test, Hiv Detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48449	HIV1/HIV2 antigen/antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03610520506493	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9 x 1.5 mL

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius