5 results
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56ms
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Sources: EU EUDAMED, US FDA
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code LLL·November 25, 2008
ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
FDA Recall
Terminated
·Immuno Concepts Inc·Product code DHN·December 4, 2008
IMMUNO CONCEPTS, NA, Ltd.
FDA registration
IMMUNO CONCEPTS, NA, Ltd.·13 products·🇺🇸 United States
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices