Total bilirubin IVD, kit, spectrophotometry

59 devices · GMDN 53229

This category includes in vitro diagnostic (IVD) kits designed to measure total bilirubin levels in clinical specimens such as blood or serum. These kits use spectrophotometry to detect and quantify bilirubin, aiding in the assessment of liver function, hemolytic disorders, and neonatal jaundice.

Devices in this category are reagent-based systems that include all necessary components for testing and are intended for use in clinical laboratories. They are regulated as IVDs and must meet performance and safety requirements for diagnostic use, though individual devices may vary in classification depending on the jurisdiction.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category

POINTE SCIENTIFIC Bilirubin, Total
POINTE SCIENTIFIC, INC. Class II
CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT BL-228
Carolina Liquid Chemistries Corp. Class II
ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents
Siemens Healthcare Diagnostics Class I
Total Bilirubin LiquiColor®
STANBIO LABORATORY, L.P. Class II
Bilirubin Total Gen.3
Roche Diagnostics Corp. Class II
TOTAL BILIRUBIN-SL-X
Sekisui Diagnostics, LLC Class II
Alinity
ABBOTT IRELAND Class I
Direct Bilirubin
Roche Diagnostics Corp. Class II
CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228
Carolina Liquid Chemistries Corp. Class II
Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Class II
ARCHITECT
ABBOTT IRELAND Class II
CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT AU-228
Carolina Liquid Chemistries Corp. Class II
Pointe Scientific, Inc.
POINTE SCIENTIFIC, INC. Class II
Bilirubin Total Gen.3
Roche Diagnostics Corp. Class II
Direct Bilirubin
Roche Diagnostics Corp. Class II
Pointe Scientific
POINTE SCIENTIFIC, INC. Class II
Thermo Scientific
Fisher Diagnostics Class II
ENVOY 500 TOTAL BILIRUBIN REAGENT KIT
VITALSCIENTIFIC
Pointe Total Bilirubin Reagent
POINTE SCIENTIFIC, INC. Class II
Direct Bilirubin
Roche Diagnostics Corp. Class II
CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 TBIL RGT KIT Product No. ST228
Carolina Liquid Chemistries Corp. Class II
Bilirubin Total Gen.3
Roche Diagnostics Corp. Class II
ENVOY 500 TOTAL BILIRUBIN REAGENT KIT
VITALSCIENTIFIC
Total Bilirubin
POINTE SCIENTIFIC, INC. Class II
Bilirubin Total Gen3
Roche Diagnostics Corp. Class II
Pointe Total Bilirubin Reagent
POINTE SCIENTIFIC, INC. Class II
Atellica CH TBil_2
Siemens Healthcare Diagnostics Class II
ARCHITECT
Abbott Laboratories, Inc. Class II
Pointe Scientific, Inc.
POINTE SCIENTIFIC, INC. Class II
Synchron
Beckman Coulter, Inc. Class II
Total Bilirubin Special
Roche Diagnostics Corp. Class II
TOTAL BILIRUBIN 2 (T BIL 2)
Randox Laboratories, Ltd. Class II
ARCHITECT
Abbott Class II
ARCHITECT
Abbott Class II
Pointe Scientific, Inc. Bilirubin, Total
POINTE SCIENTIFIC, INC. Class II
Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes
Advanced Instruments, LLC Class II
Pointe Scientific, Inc.
POINTE SCIENTIFIC, INC. Class II
Dimension Vista® Flex® reagent cartridge TBIL
Siemens Healthcare Diagnostics Class II
Bilirubin Direct
Roche Diagnostics Corp. Class II
ARCHITECT
ABBOTT IRELAND Class I
ARCHITECT
Abbott Class II
POINTE SCIENTIFIC Bilirubin, Total
POINTE SCIENTIFIC, INC. Class II
POINTE SCIENTIFIC Bilirubin, Total
POINTE SCIENTIFIC, INC. Class II
Total & Direct Bilirubin LiquiColor®
STANBIO LABORATORY, L.P. Class II
Bilirubin Total Gen3
Roche Diagnostics Corp. Class II
BILIRUBIN TOTAL 4+1
VITALSCIENTIFIC
Alinity
Abbott Class I
ABX PENTRA BILIRUBIN, TOTAL CP
Horiba Abx Class II
Pointe Scientific, Inc.
POINTE SCIENTIFIC, INC. Class II
CAROLINA LIQUID CHEMISTRIES CORP.® TBIL REAGENT PRODUCT NO. DT228
Carolina Liquid Chemistries Corp. Class II