1,026 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JFM·February 13, 2020
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HFM·September 19, 2019
Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HFM·September 11, 2019
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
FDA classification
FDA Class 2
·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
FDA classification
FDA Class 1
·Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Ige, Ferritin, Antigen, Antiserum, Control
FDA classification
FDA Class 2
·Ige, Ferritin, Antigen, Antiserum, Control