ID NOW COVID-19 2.0

GUDID 00811877011354

A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.

Alere Scarborough, Inc.

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00811877011354
• NIH Device Record Key: 70425b44-61e2-4caa-aaf4-40f79127423a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ID NOW COVID-19 2.0
• Version Model Number: 192-000
• 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: true
• 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	00811877011354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221925

FDA Product Code

• QWR: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

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: 2022-09-19
• Device Publish Date: 2022-09-09

Devices Manufactured by Alere Scarborough, Inc.

• 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
• 00811877012108 - BinaxNOW COVID-19/Flu A&B Controls: 2025-02-07 Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens