NALClass II
Test, Immunoassay, Biosensor, Hcg
Clinical Chemistry · 21 CFR 862.1155
MDR events16All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances2All time
Recent MDR events
16 adverse event reports on file
- I-STAT B-HCG CARTRIDGEAug 26, 2016MalfunctionAbbott Point Of Care2245578-2016-00090
- I-STAT B-HCG CARTRIDGEMay 20, 2016MalfunctionAbbott Point Of Care2245578-2016-00032
- I-STAT B-HCG CARTRIDGEMay 13, 2016MalfunctionAbbott Point Of Care2245578-2016-00025
- I-STAT B-HCG CARTRIDGEMay 13, 2016MalfunctionAbbott Point Of Care2245578-2016-00027
- I-STAT B-HCG CARTRIDGEMay 13, 2016MalfunctionAbbott Point Of Care2245578-2016-00023
- I-STAT B-HCG CARTRIDGEMay 13, 2016MalfunctionAbbott Point Of Care2245578-2016-00026
- I-STAT B-HCG CARTRIDGEMay 13, 2016MalfunctionAbbott Point Of Care2245578-2016-00024
- I-STAT B-HCG CARTRIDGEApr 26, 2016MalfunctionAbbott Point Of Care2245578-2016-00019
- I-STAT B-HCG CARTRIDGEMar 23, 2016MalfunctionAbbott Point Of Care2245578-2016-00017
- I-STAT B-HCG CARTRIDGEFeb 26, 2016MalfunctionAbbott Point Of Care2245578-2016-00015
Event type breakdown
Malfunction16
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