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 Issuing Agency | Device ID |
---|---|
GS1 | 00850042559116 [Unit of Use] |
GS1 | 00850042559123 [Primary] |
GS1 | 10850042559120 [Package] Contains: 00850042559123 Package: [2 Units] In Commercial Distribution |
QKP | Coronavirus Antigen Detection Test System. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-10-12 |
Device Publish Date | 2022-12-14 |
00850042559642 - CorDx Tyfast | 2024-09-12 CorDx Tyfast COVID-19 Ag Rapid Test |
10850042559915 - CorDx Tyfast | 2024-09-12 CorDx Tyfast COVID-19 Ag Rapid Test 4 tests/box |
00850042559529 - CorDx Tyfast | 2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC |
10850042559533 - CorDx Tyfast | 2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC |
10850042559557 - CorDx Tyfast | 2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC |
10850042559564 - CorDx Tyfast | 2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC |
00850042559635 - CorDx Tyfast | 2024-04-19 CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC |
10850042559656 - CorDx Tyfast | 2024-04-19 CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORDX 98520631 not registered Live/Pending |
Cordx Union Inc. 2024-04-26 |
CORDX 97220621 not registered Live/Pending |
Cordx Union Inc. 2022-01-14 |
CORDX 77169440 not registered Dead/Abandoned |
UNGER, EVAN C. 2007-04-30 |
CORDX 73467642 1308965 Dead/Cancelled |
Cincinnati Cordage and Paper Company; The 1984-02-27 |