QBXClass II
Direct Blood Bacterial Nucleic Acid Detection System
Microbiology · 21 CFR 866.3960
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
MDR events55All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
55 adverse event reports on file
- T2BACTERIA PANELDec 6, 2024MalfunctionT2 Biosystems, Inc.3010097867-2024-00031
- T2BACTERIA PANELOct 24, 2024MalfunctionT2 Biosystems, Inc.3010097867-2024-00030
- T2BACTERIA PANELOct 18, 2024MalfunctionT2 Biosystems, Inc.3010097867-2024-00029
- T2BACTERIA PANELSep 17, 2024MalfunctionT2 Biosystems, Inc.3010097867-2024-00028
- T2BACTERIA PANELSep 11, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00027
- T2BACTERIA PANELAug 13, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00026
- T2BACTERIA PANELAug 7, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00022
- T2BACTERIA PANELAug 7, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00023
- T2BACTERIA PANELAug 7, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00024
- T2BACTERIA PANELAug 7, 2024MalfunctionT2 Biosystems, Inc3010097867-2024-00025
Event type breakdown
Malfunction55
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
2 clearances for this product code