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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUALISYS AB
FDA registration
QUALISYS AB·1 product·🇸🇪 Sweden
Qualisys Clinical System
FDA UDI
Qualisys AB·07300009074518·The Qualisys Clinical System is a camera and co...
ADVIA Centaur® Zika Ab Quality Control
FDA UDI
Siemens Healthcare Diagnostics Inc.·00842768025273·ADVIA Centaur Zika Test - Zika Ab Controls
ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
FDA 510(k)
FDA Class 2
·Microbiology
cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit
FDA UDI
Roche Molecular Systems, Inc.·00875197006377·
cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code OCC·May 17, 2016
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·July 20, 2016
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Recall
Terminated
·LumiraDx·Product code QKO·June 24, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Enforcement
Class II
·Terminated·LumiraDx·July 27, 2022
ENDO STITCH
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code OCW·March 5, 2024
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
FDA Recall
Open, Classified
·Microbiologics Inc·Product code OHQ·February 20, 2025
ENDO STITCH
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code OCW·January 8, 2025
ENDO STITCH
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code OCW·January 8, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·April 2, 2025
cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System
FDA UDI
Roche Molecular Systems, Inc.·00875197005639·
ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY
FDA Adverse Event
Injury
·MERIDIAN BIOSCIENCE, INC.·Product code NJR·October 9, 2017
ALERE DETERMINE HIV 1/2 AG/AB COMBO 25T
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·June 24, 2022
cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System
FDA UDI
Roche Molecular Systems, Inc.·00875197005653·
BLOOD GROUPING REAGENT ANTI-A,B
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·March 5, 2013
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Enforcement
Class III
·Terminated·LumiraDx·November 2, 2022