QuickVue In-Line 00343

GUDID 30014613003434

QkVue InLine Strep A 25T

QUIDEL CORPORATION

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

• Primary Device ID: 30014613003434
• NIH Device Record Key: 54a15936-b2af-4f6f-9e0b-4a72e398ff53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue In-Line
• Version Model Number: 00343
• Catalog Number: 00343
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613003434 [Primary]

FDA Product Code

• GTZ: ANTISERA, 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: 2018-12-11
• Device Publish Date: 2018-11-10

On-Brand Devices [QuickVue In-Line]

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