21 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Gynius
FDA UDI
Gynius AB·07300009046461·The Gynocular is a colposcope intended to provi...
ALINITY S HIV AG/AB COMBO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code QHM·November 3, 2025
ALINITY S HIV AG/AB COMBO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code QHM·November 3, 2025
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·March 16, 2023
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·October 3, 2025
ALINITY I HIV AG/AB COMBO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code MZF·December 12, 2022
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·April 10, 2023
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·October 3, 2025
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·October 3, 2025
ALINITY S HIV AG/AB COMBO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code QHM·June 29, 2021
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·April 21, 2025
DETERMINE HIV-1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·April 22, 2025
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·April 10, 2023
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·April 10, 2023
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code MZA·October 30, 2015
ARCHITECT HIV AG/AB COMBO
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code MZF·July 5, 2017
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ORGENICS LTD·Product code MZF·April 25, 2016
ELECSYS HIV DUO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MZF·September 29, 2025
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·January 28, 2020
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·November 25, 2019