AmpliVue

Basic Information

• Brand Name: AmpliVue
• Primary DI: 30014613312093
• Version / Model: Bordetella Assay
• Catalog Number: M209
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 06bc7dfa-992a-420d-b525-03e7ffe36811
• Distribution End Date: 2020-07-20

Device Description

AmpliVue Bordetella Assay

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
OZZ	Bordetella pertussis dna assay system	Microbiology	866.3980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50505	Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen, using a nucleic acid technique (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613312093	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius