ID NOW™ COVID-19

GUDID 10811877011269

A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in respiratory specimens.

Alere Scarborough, Inc.

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

• Primary Device ID: 10811877011269
• NIH Device Record Key: 84d30b14-4efd-4a2e-bc18-9390d79ffa1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ID NOW™ COVID-19
• Version Model Number: 190-000
• 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: 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	10811877011269 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

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: 2020-04-07
• Device Publish Date: 2020-03-30

Devices Manufactured by Alere Scarborough, Inc.

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• 00811877011798 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
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