QuickVue In-Line

Basic Information

• Brand Name: QuickVue In-Line
• Primary DI: 30014613003458
• Version / Model: 00345
• Catalog Number: 00345
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-21
• Public Version: 1
• Public Version Date: 2019-03-29
• Public Version Status: New
• Public Device Record Key: 34129767-a725-4d4e-9077-b9996f1a60bd

Device Description

QkVue InLine Strep A Ctrl Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GTY	ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51712	Beta-haemolytic Group A Streptococcus antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613003458	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K945080	000