BioPlex® 2200 6653475A

GUDID 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4

BIO-RAD LABORATORIES, INC.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 03610520519813
• NIH Device Record Key: 76eff57e-f6e4-4365-9257-ee3011756db7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPlex® 2200
• Version Model Number: SW4.2_v4
• Catalog Number: 6653475A
• Company DUNS: 884513334
• Company Name: BIO-RAD LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610520519813 [Primary]

FDA Product Code

• MZF: Test, Hiv Detection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-03-22
• Device Publish Date: 2015-08-28

On-Brand Devices [BioPlex® 2200]

• 00847865019255: BioPlex 2200 HIV Ag-Ab Reagent Pack
• 00847865018487: BioPlex 2200, HIV Ag-Ab Control Lot Data
• 00847865018470: BioPlex 2200, HIV Ag-Ab Calibrator Lot Data
• 00847865011105: BioPlex® 2200 Manual Reagent Pack Piercer
• 00847865001281: U.S. IFU Manual and CDs, BioPlex 2200 HIV Ag-Ab IFU 665-3465A
• 03610520506493: BioPlex 2200, HIV Ag-Ab Control Set
• 03610520506486: BioPlex 2200 HIV Ag-Ab Calibrator Set
• 03610520519813: BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4