CorDx

GUDID 10850042559120

CorDx COVID-19 Ag Test

CORETESTS, INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

• Primary Device ID: 10850042559120
• NIH Device Record Key: 875d2b38-1f7e-4e12-ba2c-ba6d9e983675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorDx
• Version Model Number: CO291-2
• Company DUNS: 036440919
• Company Name: CORETESTS, INC.
• Device Count: 2
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042559116 [Unit of Use]
GS1	00850042559123 [Primary]
GS1	10850042559120 [Package]; Contains: 00850042559123; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• QKP: Coronavirus Antigen Detection Test 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: 2023-10-12
• Device Publish Date: 2022-12-14

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• 00850042559888 - CorDx Tyfast: 2025-03-17 CorDx Tyfast Ovulation Test Cassette
• 00850042559642 - CorDx Tyfast: 2024-09-12 CorDx Tyfast COVID-19 Ag Rapid Test