QuickVue In-Line 00345

GUDID 30014613003458

QkVue InLine Strep A Ctrl Set

QUIDEL CORPORATION

Beta-haemolytic Group A Streptococcus antigen IVD, control Beta-haemolytic Group A Streptococcus antigen IVD, control Beta-haemolytic Group A Streptococcus antigen IVD, control

• Primary Device ID: 30014613003458
• NIH Device Record Key: 34129767-a725-4d4e-9077-b9996f1a60bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue In-Line
• Version Model Number: 00345
• Catalog Number: 00345
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613003458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945080

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: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [QuickVue In-Line]

• 30014613003458: QkVue InLine Strep A Ctrl Set
• 30014613003434: QkVue InLine Strep A 25T