Alere i Strep A 2

Basic Information

• Brand Name: Alere i Strep A 2
• Primary DI: 10811877010040
• Version / Model: 734-000
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-28
• Public Version: 2
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: d944c075-dad9-4177-9e77-b703f41644a1
• Distribution End Date: 2019-06-24

Device Description

A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens.

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: No
• 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
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	862.2570	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	10811877010040	GS1

Premarket Submissions

Submission Number	Supplement Number
K173653	000