BioPlex 12013800

GUDID 03610522183692

BIO-RAD LABORATORIES, INC.

Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 03610522183692
• NIH Device Record Key: dc924cbf-0684-41c9-bf08-16740d5c1b0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPlex
• Version Model Number: SW4.3 v5.0
• Catalog Number: 12013800
• 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: false
• 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
• 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 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	03610522183692 [Primary]

FDA Product Code

• LIP: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [BioPlex]

• 03610522207992: BPX Syph Total& RPR Mnl&CD SW4.3 v5
• 03610522183692: SW4.3 v5.0