141 results
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22ms
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Sources: EU EUDAMED, US FDA
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Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·December 30, 2020
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·September 6, 2023
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
FDA Enforcement
Class II
·Ongoing·FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD·October 9, 2024
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780090
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180070
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780085
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023