ID NOW Instrument

GUDID 00811877012153

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

• Primary Device ID: 00811877012153
• NIH Device Record Key: dd46eac6-919b-4008-bb6c-7ffdcc0ffc39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ID NOW Instrument
• Version Model Number: NAT-024R
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811877012153 [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: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by Alere Scarborough, Inc.

• 00811877012153 - ID NOW Instrument: 2025-08-11The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
• 00811877012153 - ID NOW Instrument: 2025-08-11 The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abb
• 00811877012030 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012047 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012054 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012061 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012078 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012085 - BinaxNOW COVID-19/Flu A&B Combo Self Test: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
• 00811877012092 - BinaxNOW COVID-19/Flu A&B: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens