Platelia 12015289

GUDID 03610522220519

Platelia SARS-CoV-2 Total Ab

BIO-RAD

SARS-CoV-2 total antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 03610522220519
• NIH Device Record Key: 1ffde3c0-a900-4f77-85bc-de7e859ffa13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Platelia
• Version Model Number: 12015289
• Catalog Number: 12015289
• Company DUNS: 269902602
• Company Name: BIO-RAD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@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 Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610522220519 [Primary]

FDA Product Code

• QKO: Reagent, coronavirus serological

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: 2023-07-11
• Device Publish Date: 2023-07-03

On-Brand Devices [Platelia]

• 03610522220526: Platelia SARS-CoV-2 Total Ab
• 03610522220519: Platelia SARS-CoV-2 Total Ab
• 03610520007877: PLATELIA Lyme IgG
• 03610520007860: PLATELIA Lyme IgM