CorDx Tyfast
GUDID 00850042559529
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical| Primary Device ID | 00850042559529 |
| NIH Device Record Key | 8d1e406a-9d9e-4472-8078-795c97661d49 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CorDx Tyfast |
| Version Model Number | ACT21002-1 |
| Company DUNS | 036440919 |
| Company Name | CORETESTS, 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 | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850042559529 [Primary] |
| GS1 | 10850042559526 [Package] Package: [150 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 | 2024-06-21 |
| Device Publish Date | 2024-06-13 |
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 |
Trademark Results [CorDx Tyfast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORDX TYFAST 98520642 not registered Live/Pending |
Cordx Union Inc. 2024-04-26 |
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