QuickVue 20399

GUDID 30014613339687

QuickVue At-Home OTC COVID-19 Test

QUIDEL CORPORATION

SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 30014613339687
• NIH Device Record Key: 9633a588-94e0-4f5e-a0e4-427c84e93ba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue
• Version Model Number: 20399
• Catalog Number: 20399
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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
• 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	30014613339687 [Primary]

FDA Product Code

• QKP: Coronavirus antigen detection test system.

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: 2021-05-10
• Device Publish Date: 2021-04-30

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