24 results
·
45ms
·
Sources: EU EUDAMED, US FDA
DIATRUSTTM COVID-19 AG RAPID TEST
FDA Adverse Event
Malfunction
·HUMASIS CO., LTD.·Product code QKP·October 18, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Open, Classified
·CELLTRION USA INC·Product code QKP·February 25, 2022
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
FDA Adverse Event
Malfunction
·CELLTRION USA, INC.·Product code QKP·October 23, 2023
CELLTRION DIATRUST
FDA Adverse Event
Malfunction
·CELLTRION USA, INC.·Product code QKP·December 27, 2023
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
FDA Adverse Event
Malfunction
·CELLTRION USA, INC.·Product code QKP·October 23, 2023
CELLTRION DIATRUST COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC.·Product code QKP·November 9, 2023
CELLTRION DIATRUST COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC.·Product code QKP·November 9, 2023
CELLTRION DIATRUST COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA, INC.·Product code QKP·December 1, 2023
CELLTRION DIATRUST COVID 19 ANTIGEN TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC.·Product code QKP·September 15, 2022
CELLTRION DIATRUST COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·HUMASIS INC. / CELLTRION USA, INC.·Product code QKP·January 19, 2024
COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC. / HUMASIS CO., LTD.·Product code QKP·November 7, 2023
COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC. / HUMASIS CO., LTD.·Product code QKP·November 7, 2023
CELLTRION DIATRUST COVID TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC./ HUMASIS CO., LTD·Product code QKP·October 11, 2023
CELLTRION DIATRUST COVID-19 AG HOME TEST
FDA Adverse Event
Malfunction
·CELLTRION USA INC. / HUMASIS CO., LTD.·Product code QKP·November 24, 2023
COVID-19 AG
FDA Adverse Event
Malfunction
·CELLTRION USA INC. / HUMASIS CO. LTD·Product code QKP·October 6, 2023
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·April 1, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·December 1, 2021
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·December 2, 2021
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·December 28, 2021
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Enforcement
Class I
·Terminated·CELLTRION USA INC·May 4, 2022