CFQClass II

Radioimmunoassay, Immunoglobulins (g, A, M)

Immunology · 21 CFR 866.5510

MDR events7All time

Recalls0All time

Registered firms13Currently listed

510(k) clearances12All time

Recent MDR events

7 adverse event reports on file

BN II SYSTEMAug 31, 2018
MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2018-00084
DIMENSION®Nov 3, 2016
MalfunctionSiemens Healthcare Diagnostics Inc - Glasgow2517506-2016-00351
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEMAug 30, 2012
MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2012-00011
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEMAug 16, 2012
MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2012-00009
DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEMAug 1, 2012
MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2012-00008
MTS ANTI-IGG, -C3D CARDMay 8, 2009
MalfunctionMicro Typing Systems, Inc,1056600-2009-00097
VITROS IMMUNODIAGNOSTICS PRODUCTS AHAV IGM REAGENT PACKApr 3, 2008
MalfunctionOrtho-clinical Diagnostics9680658-2008-00091

Event type breakdown

Malfunction7

Most-reported manufacturers

Siemens Healthcare Diagnostics Products Gmbh4 Micro Typing Systems, Inc,1 Ortho-clinical Diagnostics1 Siemens Healthcare Diagnostics Inc - Glasgow1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

13 firms currently registered for this product code

510(k) clearances

12 clearances for this product code