Codiagnostics

FDA Filings

This page includes the latest FDA filings for Codiagnostics. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3014214006
FEI Number3014214006
NameCODIAGNOSTICS
Owner & OperatorCodiagnostics
Contact Address2401 Foothill Dr. Ste D
Salt Lake City UT 84109 US
Official Correspondent
  • Cecilia Hutchins
  • x-801-4381036-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2401 Foothill Dr. Ste D
Salt Lake City, UT 84109 US
Establishment TypeManufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
CODIAGNOSTICS
Logix Smart Coronavirus Disease 2019 (COVID-19) - 5,000 reactions2020-03-05
CODIAGNOSTICS
Logix Smart Coronavirus Disease 2019 (COVID-19) - 250 reactions2020-03-05
CODIAGNOSTICS
Logix Smart Coronavirus Disease 2019 (COVID-19) - 100 reactions2020-03-05
CODIAGNOSTICS
Logix Smart ZDC (ZIKV, DENV, CHIKV)2018-11-15
CODIAGNOSTICS
Logix Smart MAL2018-11-15
CODIAGNOSTICS
Logix Smart HPV2018-11-15
CODIAGNOSTICS
Logix Smart HIV2018-11-15
CODIAGNOSTICS
Logix Smart HCV2018-11-15
CODIAGNOSTICS
Logix Smart HBV2018-11-15
CODIAGNOSTICS
Logix Smart DENV2018-11-15
CODIAGNOSTICS
Logix Smart ZIKV2018-11-15
CODIAGNOSTICS
Logix Smart ZDC (ZIKV, DENV, CHIKV)2018-11-15
CODIAGNOSTICS
Logix Smart MAL2018-11-15
CODIAGNOSTICS
Logix Smart HPV2018-11-15
CODIAGNOSTICS
Logix Smart HIV2018-11-15
CODIAGNOSTICS
Logix Smart HCV2018-11-15
CODIAGNOSTICS
Logix Smart HBV2018-11-15
CODIAGNOSTICS
Logix Smart DENV2018-11-15
CODIAGNOSTICS
Logix Smart ZIKV2016-09-26
CODIAGNOSTICS
Logix Smart ZDC (ZIKV, DENV, CHIKV)2016-09-26
CODIAGNOSTICS
Mycobacterium Tuberculosis Drug Resistance Panel Kit2016-09-26
CODIAGNOSTICS
Logix Smart MTB2016-09-26

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