AmpliVue

Basic Information

• Brand Name: AmpliVue
• Primary DI: 30014613312123
• Version / Model: Group A Strep Assay
• Catalog Number: M212
• 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: 2023-07-11
• Public Version Status: Update
• Public Device Record Key: c274905a-e456-4fc3-8c58-6948350a94fe
• Distribution End Date: 2020-07-20

Device Description

AmpliVue GAS 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
PGX	Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system	Microbiology	866.2680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51714	Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria 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	30014613312123	GS1

Customer Contacts

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

Storage Conditions

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