BioPlex 12013800

GUDID 03610522183692

BIO-RAD LABORATORIES, INC.

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