Alere i Strep A 2 Control Swab Kit

Basic Information

• Brand Name: Alere i Strep A 2 Control Swab Kit
• Primary DI: 10811877010200
• Version / Model: 734-080
• 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: b1b7776c-a82e-4445-be68-ac4929cc5479
• Distribution End Date: 2020-09-28

Device Description

Control Swabs intended for use only with the Alere i Strep A 2 product.

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
51716	Beta-haemolytic Group A Streptococcus nucleic acid IVD, control	A material which is used to verify the performance of an assay 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010200	GS1

Premarket Submissions

Submission Number	Supplement Number
K173653	000