QuickVue+ 00179

GUDID 30014613001799

QkVue+ hCG S/U, 90T

QUIDEL CORPORATION

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody Human chorionic gonadotropin beta-subunit IVD, antibody

• Primary Device ID: 30014613001799
• NIH Device Record Key: 6dae40eb-f72a-4e8a-9ef9-0cbda16a4d64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue+
• Version Model Number: hCG S/U Test
• Catalog Number: 00179
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613001799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973858

FDA Product Code

• JHI: Visual, pregnancy hCG, prescription use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-06
• Device Publish Date: 2016-09-14

On-Brand Devices [QuickVue+]

• 30014613201229: QkVue+ Strep A, 25T
• 30014613201212: QuickVue+ Mononucleosis 20T
• 30014613001799: QkVue+ hCG S/U, 90T
• 30014613001782: QkVue+ hCG S/U, 30T