Anti-sm Antibody, Antigen And Control
Immunology · 21 CFR 866.5100
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
20 firms currently registered for this product code
Phadia Us Inc.
Portage, MI, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Steris Schweiz Ag
Daniken Solothurn, CH
Phadia Gmbh
FREIBURG Baden-Wurttemberg, DE
Phadia Ab
Uppsala, SE
Immco Diagnostics, Inc.
Williamsville, NY, US
Phadia Ab
UPPSALA, SE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Bio-rad Laboratories, Inc.
Hercules, CA, US
Theratest Laboratories, Inc.
Lombard, IL, US
Theradiag
MARNE LA VALLEE CEDEX 2 Seine-et-Marne, FR
510(k) clearances
28 clearances for this product code
- Phadia ABJul 14, 2021
K202067 · EliA SmDP-S
- Phadia ABDec 24, 2018
K183007 · EliA SmDP Immunoassay
- Phadia US, Inc.Aug 29, 2014
K132631 · EIA SMDP IMMUNOASSAY
- Inova Diagnostics, Inc.Apr 17, 2013
K123593 · QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
- Theratest Laboratories, Inc.Oct 7, 2005
K051066 · THERATEST EL-ANA PROFILES
- Sweden Diagnostics (Germany) GmbHDec 8, 2004
K042629 · VARELISA SM ANTIBODIES, MODEL 18296
- Bio-RadJan 15, 2003
K024219 · LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
- Fred Hutchinson Cancer Research CenterJul 29, 2002
K013263 · FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST