Alere™ i Instrument

GUDID 00811877010821

The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays.

Alere Scarborough, Inc.

Isothermal nucleic acid amplification analyser IVD, laboratory, semi-automated

• Primary Device ID: 00811877010821
• NIH Device Record Key: 25d898b5-005e-450f-95d8-9e4adce5d4d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere™ i Instrument
• Version Model Number: EQ00200X
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811877010821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141520

FDA Product Code

• OOI: Real Time 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: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [Alere™ i Instrument]

• 00811877010838: The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for t
• 00811877010821: The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for t