Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Immunology · 21 CFR 866.5660
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
19 firms currently registered for this product code
Euroimmun Us Inc.
Mountain Lakes, NJ, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Zeus Scientific Llc
BRANCHBURG, NJ, US
Steris Schweiz Ag
Daniken Solothurn, CH
Inova Diagnostics, Inc.
SAN DIEGO, CA, US
Phadia Us Inc.
Portage, MI, US
Euroimmun Medizinische Labordiagnostika Ag
Luebeck Schleswig-Holstein, DE
Phadia Ab
Uppsala, SE
Euroimmun Medizinische Labordiagnostika Ag
Dassow Mecklenburg-Western Pomerania, DE
Phadia Ab
UPPSALA, SE
Immco Diagnostics, Inc.
Williamsville, NY, US
Bio-rad Laboratories, Inc.
Woodinville, WA, US
Instrumentation Laboratory Spa
Roncello Lombardy, IT
Theradiag
MARNE LA VALLEE CEDEX 2 Seine-et-Marne, FR
510(k) clearances
6 clearances for this product code
- Zeus Scientific, Inc.Dec 6, 2007
K071219 · ATHENA MULTI-LYTE GBM TEST SYSTEM
- Bio-Rad LaboratoriesOct 31, 2007
K072358 · BIOPLEX VASCULITIS KIT
- Scimedx Corp.Jun 25, 2001
K011348 · PHASE II GBM IGG ANTIBODY EIA TEST
- Cogent Diagnotics , Ltd.Aug 9, 1999
K991890 · AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
- The Binding Site, Ltd.Feb 23, 1999
K984619 · BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
- Inova Diagnostics, Inc.Feb 8, 1999
K984336 · QUANTA LITE GBM ELISA