Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use
Immunology · 21 CFR 866.4750
Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.
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Registered firms
28 firms currently registered for this product code
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Immuno Concepts, Na, Ltd.
SACRAMENTO, CA, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Phadia Us Inc.
Portage, MI, US
Visia Lab Srl
SAN GIOVANNI VALDARNO Arezzo, IT
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Zeus Scientific Llc
BRANCHBURG, NJ, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Aesku.diagnostics Gmbh&co.kg
WENDELSHEIM Rhineland-Palatinate, DE
510(k) clearances
2 clearances for this product code