CorDx Tyfast

GUDID 00850042559642

CorDx Tyfast COVID-19 Ag Rapid Test

CORETESTS, INC.

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

• Primary Device ID: 00850042559642
• NIH Device Record Key: 7499e0bf-39be-416a-bc59-11b49a03a4c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorDx Tyfast
• Version Model Number: ACT21003-2B
• 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	00850042559642 [Unit of Use]
GS1	00850042559673 [Primary]
GS1	10850042559670 [Package]; Contains: 00850042559673; Package: [90 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240728

FDA Product Code

• QYT: Over-The-Counter Covid-19 Antigen Test

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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [CorDx Tyfast]

• 10850042559656: CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
• 00850042559635: CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
• 10850042559564: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559557: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559533: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 00850042559529: CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
• 10850042559915: CorDx Tyfast COVID-19 Ag Rapid Test 4 tests/box
• 00850042559642: CorDx Tyfast COVID-19 Ag Rapid Test