POCClass II
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Microbiology · 21 CFR 866.1640
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
MDR events5All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances4All time
Recent MDR events
5 adverse event reports on file
- XPERT CARBA-RAug 11, 2025MalfunctionCepheid3004530258-2025-00022
- KIT BD MAX CPOFeb 27, 2023MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2023-00007
- KIT BD MAX CHECK-POINTS CPO IVDFeb 23, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00171
- BD MAX¿ CHECK-POINTS CPOMar 3, 2022MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2022-00002
- KIT BD MAX CHECK-POINTS CPO IVDJun 3, 2021MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2021-00017
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
4 clearances for this product code