Sofia 2 20405

GUDID 30014613339755

Sofia 2 SARS Ag + FIA

QUIDEL CORPORATION

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 30014613339755
• NIH Device Record Key: 92caa66c-ec84-4061-a1ce-f42b9b879a57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofia 2
• Version Model Number: 20405
• Catalog Number: 20405
• Company DUNS: 079509836
• Company Name: QUIDEL CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613339755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220039

FDA Product Code

• QVF: Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings

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: 2023-04-05
• Device Publish Date: 2023-03-28

Devices Manufactured by QUIDEL CORPORATION

• 30014613336747 - InflammaDry: 2023-06-16 InflammaDry
• 30014613336754 - InflammaDry: 2023-06-16 InflammaDry
• 30014613339755 - Sofia 2: 2023-04-05Sofia 2 SARS Ag + FIA
• 30014613339755 - Sofia 2: 2023-04-05 Sofia 2 SARS Ag + FIA
• 30014613202783 - Solana: 2022-06-10 Solana instrument
• 30014613339670 - QuickVue: 2021-05-14 QuickVue At-Home OTC COVID-19 Test
• 30014613339687 - QuickVue: 2021-05-10 QuickVue At-Home OTC COVID-19 Test
• 30014613339724 - QuickVue: 2021-05-10 QuickVue At-Home OTC COVID-19 Test
• 30014613339083 - Sofia: 2021-02-25 Sofia® SARS Antigen FIA