Alere i Strep A 2 Control Swab Kit

GUDID 10811877010200

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

Alere Scarborough, Inc.

Beta-haemolytic Group A Streptococcus nucleic acid IVD, control

• Primary Device ID: 10811877010200
• NIH Device Record Key: b1b7776c-a82e-4445-be68-ac4929cc5479
• Commercial Distribution Discontinuation: 2020-09-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Alere i Strep A 2 Control Swab Kit
• Version Model Number: 734-080
• Company DUNS: 154148498
• Company Name: Alere Scarborough, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173653

FDA Product Code

• PGX: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-12
• Device Publish Date: 2018-06-28

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