QuickVue 0B006

GUDID 30014613200062

QkVue Chlamydia 25T

QUIDEL CORPORATION

Multiple Chlamydia species antigen IVD, kit, immunochromatographic test (ICT), rapid Multiple Chlamydia species antigen IVD, kit, immunochromatographic test (ICT), rapid Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 30014613200062
• NIH Device Record Key: 6a1e4121-86bf-44c7-8992-0f3b445db24a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickVue
• Version Model Number: 0B006
• Catalog Number: 0B006
• 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	30014613200062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946276

FDA Product Code

• LJC: ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP)

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

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