AmpliVue

Basic Information

• Brand Name: AmpliVue
• Primary DI: 30014613312024
• Version / Model: GBS Assay
• Catalog Number: M202
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-30
• Public Version: 3
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: aab63298-b2df-4848-9c07-25a65dd96b91
• Distribution End Date: 2020-07-27

Device Description

AmpliVue GBS 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
NJR	Nucleic acid amplification assay system, group b streptococcus, direct specimen test	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61066	Multiple-type neonatal pathogen nucleic acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with neonatal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include, but are not limited to, Group B Streptococcus/Streptococcus agalactiae (GBS), Listeria monocytogenes, Escherichia coli (E. coli), cytomegalovirus, Staphylococcus aureus, Chlamydia trachomatis and Ureaplasma urealyticum/parvum.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613312024	GS1

Customer Contacts

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