NGSClass II
Assay, Endotoxin Activity, Chemiluminescent
Microbiology · 21 CFR 866.3210
MDR events8All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances2All time
Recent MDR events
8 adverse event reports on file
- COBAS 6000 C501 (UL) VNov 12, 2013MalfunctionRoche Diagnostics1823260-2013-06822
- COBAS 6000 C501MODULEJul 10, 2013MalfunctionRoche Diagnostics1823260-2013-04177
- DIMENSION VISTA 500Jul 9, 2013MalfunctionSiemens Healthcare Diagnostics Inc.1226181-2013-00305
- UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEMMay 8, 2013MalfunctionBeckman Coulter2050012-2013-00327
- DIMENSION EXLMay 8, 2013MalfunctionSiemens Healthcare Diagnostics1226181-2013-00210
- ARCHITECT C8000 SYSTEMMay 7, 2013MalfunctionAbbott Manufacturing Inc1628664-2013-00116
- AU5800 CLINICAL CHEMISTRY ANALYZERMay 3, 2013MalfunctionBeckman Coulter9612296-2013-00059
- DIMENSION CLINICAL CHEMSITRY SYSTEMMay 3, 2013MalfunctionSiemens Healthcare Diagnostics Inc1226181-2013-00199
Event type breakdown
Malfunction8
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code