3,994 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QKO (TM) AMYLASE B-HA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COVID-19 ANTIBODY COMPREHENSIVE TEST
FDA Adverse Event
Malfunction
·UNK·Product code QKO·January 4, 2023
ATELLICA IM SARS-COV-2 TOTAL (COV2T)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code QKO·June 23, 2020
VIDAS SARS-COV-2 IGG (9COG) 60T
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·June 24, 2021
ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code QKO·June 22, 2021
ELECSYS ANTI-SARS-COV-2 S
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code QKO·May 4, 2021
LIAISON SARS-COV-2 S1/S2 IGG
FDA Adverse Event
Malfunction
·DIASORIN S.P.A.·Product code QKO·June 15, 2021
ADVIA CENTAUR XP SARS-COV-2 IGG (SCOVG)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code QKO·May 24, 2021
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·June 11, 2021
SARS-COV-2 IGM
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·April 16, 2021
LIAISON SARS-COV-2 IGM
FDA Adverse Event
Malfunction
·DIASORIN S.P.A.·Product code QKO·May 18, 2021
ACCESS SARS-COV-2 ANTIGEN
FDA Adverse Event
Malfunction
·CLARE DISCRETE MFG IO·Product code QKO·April 28, 2021
LIAISON SARS-COV-2 S1/S2 IGG
FDA Adverse Event
Malfunction
·DIASORIN S.P.A.·Product code QKO·June 13, 2021
ACCESS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·CLARE DISCRETE MFG IO·Product code QKO·June 8, 2021
VIDAS SARS-COV-2 IGG
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·May 14, 2021
LIAISON SARS-COV-2 S1/S2 IGM
FDA Adverse Event
Malfunction
·DIASORIN S.P.A.·Product code QKO·June 13, 2021
VIDAS SARS-COV-2 IGG (9COG) 60T
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code QKO·June 24, 2021
SARS-COV-2 IGG II QUANT REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·April 13, 2021
SARS-COV-2 IGG II QUANT REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·June 16, 2021
SARS-COV-2 IGG II QUANT REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND·Product code QKO·May 21, 2021