Anti-rnp 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 Gmbh
FREIBURG Baden-Wurttemberg, DE
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Phadia Ab
Uppsala, SE
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Phadia Ab
UPPSALA, SE
Phadia Us Inc.
Portage, MI, US
Steris Schweiz Ag
Daniken Solothurn, CH
Bio-rad Laboratories, Inc.
Hercules, CA, US
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Theratest Laboratories, Inc.
Lombard, IL, US
Theradiag
MARNE LA VALLEE CEDEX 2 Seine-et-Marne, FR
510(k) clearances
23 clearances for this product code
- Genalyte, Inc.Oct 25, 2019
K191085 · Maverick RNP Assay and Maverick Diagnostic System
- Euroimmun USDec 9, 2014
K140224 · EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
- Euroimmun USJun 12, 2013
K123261 · EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
- Phadia US, Inc.May 28, 2009
K083117 · ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- Biomedical Diagnostics (Bmd) SADec 19, 2007
K071210 · MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
- Rhigene, Inc.Aug 14, 2002
K022017 · RHIGENE MESACUP-2 TEST RNP, MODEL M7741
- Rhigene, Inc.May 9, 2000
K000752 · RHIGENE MESACUP2 TEST- RNP
- Pharmacia & Upjohn Co.Nov 26, 1999
K993589 · VARELISA RNP ANTIBODIES