CorDx

GUDID 10850042559120

CorDx COVID-19 Ag Test

CORETESTS, INC.

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Primary Device ID10850042559120
NIH Device Record Key875d2b38-1f7e-4e12-ba2c-ba6d9e983675
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorDx
Version Model NumberCO291-2
Company DUNS036440919
Company NameCORETESTS, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042559116 [Unit of Use]
GS100850042559123 [Primary]
GS110850042559120 [Package]
Contains: 00850042559123
Package: [2 Units]
In Commercial Distribution

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-12
Device Publish Date2022-12-14

Devices Manufactured by CORETESTS, INC.

00850042559642 - CorDx Tyfast2024-09-12 CorDx Tyfast COVID-19 Ag Rapid Test
10850042559915 - CorDx Tyfast2024-09-12 CorDx Tyfast COVID-19 Ag Rapid Test 4 tests/box
00850042559529 - CorDx Tyfast2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
10850042559533 - CorDx Tyfast2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
10850042559557 - CorDx Tyfast2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
10850042559564 - CorDx Tyfast2024-06-21 CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
00850042559635 - CorDx Tyfast2024-04-19 CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
10850042559656 - CorDx Tyfast2024-04-19 CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC

Trademark Results [CorDx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORDX
CORDX
98520631 not registered Live/Pending
Cordx Union Inc.
2024-04-26
CORDX
CORDX
97220621 not registered Live/Pending
Cordx Union Inc.
2022-01-14
CORDX
CORDX
77169440 not registered Dead/Abandoned
UNGER, EVAN C.
2007-04-30
CORDX
CORDX
73467642 1308965 Dead/Cancelled
Cincinnati Cordage and Paper Company; The
1984-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.