QuickVue 20152

GUDID 30014613201526

QkVue Strep A Dpstk 10T

QUIDEL CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 30014613201526
• NIH Device Record Key: 7d6acf23-9b72-4aab-a67d-09876e15a773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue
• Version Model Number: 20152
• Catalog Number: 20152
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613201526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011097

FDA Product Code

• GTY: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

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: 2019-03-15
• Device Publish Date: 2019-03-07

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• 30014613320104: QkVue H pylori gII 30T
• 30014613320098: QkVue H pylori gII 10T
• 30014613202226: QkVue RSV 10, 25T
• 30014613202059: QuickVue iFOB Test Dev Kit 100T
• 30014613202042: QuickVue iFOB Collect Kit 40T
• 30014613202011: QuickVue iFOB Tray Pack 50T
• 30014613201960: QuickVue iFOB Collect Kit 10T
• 30014613201946: QuickVue iFOB 20T
• 30014613201939: QkVue RSV 20T
• 30014613201830: QkVue Flu A+B 25T, CE
• 30014613201526: QkVue Strep A Dpstk 10T
• 30014613201250: QkVue Strep A Dpstk 25T
• 30014613201120: RpdVue hCG 25T
• 30014613201106: QkVue HCG Combo, 50T
• 30014613201090: QkVue hCG Urine 25T
• 30014613201083: QkVue Strep A Dpstk 50T
• 30014613200062: QkVue Chlamydia 25T
• 30014613003540: Strep A Liquid Ctrl
• 30014613002819: hCG Ctrl Set - Serum
• 30014613002727: hCG Ctrl Set - Urine
• 30014613331469: QkVue Flu A+B 20K-T, Bulk
• 30014613201977: QkVue iFOB Control Set
• 30014613339373: QuickVue® SARS Antigen Test
• 30014613339724: QuickVue At-Home OTC COVID-19 Test
• 30014613339687: QuickVue At-Home OTC COVID-19 Test
• 30014613339670: QuickVue At-Home OTC COVID-19 Test