ID NOW™ Instrument

GUDID 00811877010616

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

Alere Scarborough, Inc.

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

• Primary Device ID: 00811877010616
• NIH Device Record Key: da6e9cb5-fec5-4f37-a74a-732f4e2acdbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ID NOW™ Instrument
• Version Model Number: EQ00200XS
• 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	00811877010616 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-29
• Device Publish Date: 2018-10-29

On-Brand Devices [ID NOW™ Instrument]

• 00811877010616: The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for th
• 00811877010593: The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for th