QuickVue

Basic Information

• Brand Name: QuickVue
• Primary DI: 30014613201977
• Version / Model: 20197
• Catalog Number: 20197
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-23
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: b10719ca-fd2e-4cbc-8edf-91ef99288745

Device Description

QkVue iFOB Control 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: Yes
• 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
KHE	REAGENT, OCCULT BLOOD	Hematology	864.6550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38218	Faecal occult blood IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613201977	GS1

Customer Contacts

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