CorDx Tyfast

GUDID 00850042559635

CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC

CORETESTS, INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

• Primary Device ID: 00850042559635
• NIH Device Record Key: 5c9f894e-78a7-4906-b061-877829c65498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CorDx Tyfast
• Version Model Number: ACT21001-25
• Company DUNS: 036440919
• Company Name: CORETESTS, INC.
• Device Count: 25
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042559512 [Unit of Use]
GS1	00850042559635 [Primary]
GS1	10850042559632 [Package]; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• QMN: Covid-19 Multi-Analyte Antigen Device

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: 2024-04-19
• Device Publish Date: 2024-04-11

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