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 SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Primary Device ID00850042559635
NIH Device Record Key5c9f894e-78a7-4906-b061-877829c65498
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorDx Tyfast
Version Model NumberACT21001-25
Company DUNS036440919
Company NameCORETESTS, INC.
Device Count25
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850042559512 [Unit of Use]
GS100850042559635 [Primary]
GS110850042559632 [Package]
Package: [20 Units]
In Commercial Distribution

FDA Product Code

QMNCovid-19 Multi-Analyte Antigen Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-19
Device Publish Date2024-04-11

On-Brand Devices [CorDx Tyfast]

10850042559656CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
00850042559635CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
10850042559564CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
10850042559557CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
10850042559533CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
00850042559529CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC

Trademark Results [CorDx Tyfast]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORDX TYFAST
CORDX TYFAST
98520642 not registered Live/Pending
Cordx Union Inc.
2024-04-26

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