6 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
FDA Recall
Open, Classified
·Quidel Corporation·Product code QMN·January 3, 2024
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
FDA Recall
Open, Classified
·Quidel Corporation·Product code GTY·April 6, 2026
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
FDA Recall
Open, Classified
·Quidel Corporation·Product code DBA·February 1, 2023
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
FDA Recall
Open, Classified
·Quidel Corporation·Product code GTY·June 17, 2025
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
FDA Recall
Open, Classified
·Quidel Corporation·Product code PFQ·March 5, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
FDA Recall
Open, Classified
·Quidel Corporation·Product code PFQ·March 5, 2024