Diazo Colorimetry, Bilirubin
FDA product code CIG · Class II (moderate risk) · 21 CFR 862.1110 · Clinical Chemistry
235510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Em Diagnostic Systems, Inc. 21
- Abbott Laboratories 15
- Data Medical Associates, Inc. 10
- Synermed, Inc. 7
- Harleco 6
- Diagnostic Chemicals, Ltd. (Usa) 5
- Olympus Corp. 4
- Pointe Scientific, Inc., 4
- J.T. Baker Chemical Co. 4
- Catachem, Inc. 4
- Trace Scientific , Ltd. 4
- American Research Products Co. 4
- Roche Diagnostics Corp. 4
- J. D. Assoc. 3
- Beckman Instruments, Inc. 3
- Medical Analysis Systems, Inc. 3
- American Dade 3
- Roche Diagnostic Systems, Inc. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Instrumentation Laboratory CO 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/27/2026SE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/12/2023SE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/20/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | Abbott Ireland Diagnostics Division | 12/29/2022SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/26/2019SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | Elitechgroup | 07/11/2017SE |
| K150510 | Total BilirubinCIG · Traditional | Abbott Laboratories | 04/02/2015SE |
| K131544 | Cobas C Bilirubin Total GEN.3CIG · Traditional | Roche Diagnostics | 07/17/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | Medica Corp. | 03/01/2013SE |
| K123965 | Cobas Integra Bilirubin Direct GEN.2CIG · Traditional | Roche Diagnostics | 02/28/2013SE |
| K121985 | Architect Total BilirubinCIG · Traditional | Abbott Laboratories | 02/01/2013SE |
| K110780 | Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…CIG · Traditional | Elitechgroup | 10/07/2011SE |
| K111143 | Poly-Chem 90 Total BilirubinCIG · Traditional | Polymedco, Inc. | 09/01/2011SE |
| K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…CIG · Traditional | Instrumentation Laboratory CO | 06/18/2010SE |
| K091991 | Easy Ra D Bil Reagent Model 10212, Easy Ra Glu-H Reagent Model 10200CIG · Special | Medica Corp. | 09/04/2009SE |
| K081193 | Cobas Integra 400/800 Bilirubin TotalCIG · Special | Roche Diagnostics | 01/16/2009SE |
| K082210 | Total Bilirubin L3K, Model 295-10 and 295-30CIG · Traditional | Genzyme Diagnostics P.E.I., Inc. | 12/16/2008SE |
| K080810 | Easyra Bilirubin Direct and Total Reagent, Phosphorus Inorganic Reagent and Iron and…CIG · Traditional | Medica Corp. | 12/10/2008SE |
| K080435 | Olympus Direct Bilirubin Reagent, Model OSR6X181CIG · Traditional | Olympus Life Science Research Europa GmbH (Europa) | 09/05/2008SE |
| K063744 | Cobas Integra C 111CIG · Special | Rochdiag | 01/17/2007SE |
| K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models 20737496 322…CIG · Special | Roche Diagnostics Corp. | 12/22/2006SE |
| K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+CIG · Traditional | Nova Biomedical Corp. | 11/01/2006SE |
| K061839 | Dimension Vista Dbil Flex Reagent Cartridge, Model K2125CIG · Traditional | Dade Behring, Inc. | 08/29/2006SE |
| K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator…CIG · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…CIG · Traditional | Horiba Abx | 08/16/2006SE |
| K060574 | Total BilirubinCIG · Traditional | Abbott Laboratories | 05/03/2006SE |
| K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorCIG · Special | Dade Behring, Inc. | 04/06/2006SE |
| K050869 | Modification to ABL800 FlexCIG · Special | Radiometer Medical Aps | 08/11/2005SE |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin TestsCIG · Traditional | Arkray, Inc. | 06/17/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | Pointe Scientific, Inc., | 06/02/2004SE |
| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | Clinical Data, Inc. | 03/18/2004SE |
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | Elan Diagnostics | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | Elan Diagnostics | 09/26/2003SE |
| K024116 | Wiener Lab. Bilirubina Direct AaCIG · Traditional | Wiener Laboratories Saic | 02/12/2003SE |
| K023330 | Bilirubin-Sl (Total) Assay, Model 284-10/30CIG · Traditional | Diagnostic Chemicals , Ltd. | 12/11/2002SE |
| K022962 | Wiener Lab. Bilirrubina Total AaCIG · Traditional | Wiener Laboratories Saic | 11/01/2002SE |
| K022339 | Total BilirubinCIG · Traditional | Abbott Laboratories | 09/13/2002SE |
| K022180 | Direct BilirubinCIG · Traditional | Abbott Laboratories | 09/06/2002SE |
| K011972 | Direct Bilirubin ReagentCIG · Traditional | Intersect Systems, Inc. | 08/27/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | Intersect Systems, Inc. | 02/20/2001SE |
| K003829 | Total BilirubinCIG · Traditional | Jas Diagnostics, Inc. | 02/12/2001SE |
| K003693 | Direct BilirubinCIG · Traditional | Jas Diagnostics, Inc. | 01/29/2001SE |
| K993867 | Bayer Advia Ims SystemCIG · Traditional | Bayer Corp. | 04/10/2000SE |
| K993771 | Careside Direct BilirubinCIG · Traditional | Careside, Inc. | 12/27/1999SE |
| K991866 | Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04CIG · Traditional | A.P. Total Care, Inc. | 08/02/1999SE |
| K991175 | Modification to Alcyon Direct BilirubinCIG · Traditional | Abbott Laboratories | 05/28/1999SE |
| K983304 | Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional | Synermed Intl., Inc. | 11/04/1998SE |
| K983133 | TbilCIG · Traditional | Abbott Laboratories | 09/16/1998SE |
| K972382 | Ub Analyzer UA-2, Reagent Kit and Bilirubin ControlCIG · Traditional | Arrows Co., Ltd. | 09/14/1998SE |
| K981943 | DbilCIG · Traditional | Abbott Laboratories | 07/22/1998SE |
| K981883 | Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent…CIG · Traditional | Boehringer Mannheim Corp. | 07/07/1998SE |
| K981588 | Careside Total BilirubinCIG · Traditional | Careside, Inc. | 06/23/1998SE |
| K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentCIG · Traditional | Roche Diagnostics/Boehringer Mannheim GmbH | 06/15/1998SE |
| K981609 | Bilirubin-Sl (Direct) Assay Catalogue Number 247-10,247-30CIG · Traditional | Diagnostic Chemicals , Ltd. | 06/03/1998SE |
| K981336 | TbilCIG · Traditional | Abbott Laboratories | 05/01/1998SE |
| K981276 | N-Assay L D-BilCIG · Traditional | Crestat Diagnostics, Inc. | 05/01/1998SE |
| K981289 | N-Assay L T-BilCIG · Traditional | Crestat Diagnostics, Inc. | 04/27/1998SE |
| K981222 | Direct Bilirubin (Dbil)CIG · Traditional | Abbott Laboratories | 04/24/1998SE |
| K974874 | Bilirubin-Sl (Total) AssayCIG · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 02/12/1998SE |
| K973109 | Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 09/25/1997SE |
| K972716 | Synermed Total Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 08/07/1997SE |
| K972073 | Total Bilirubin ReagentCIG · Traditional | Carolina Liquid Chemistries Corp. | 06/24/1997SE |
| K970986 | Wako Direct Bilirubin VCIG · Traditional | Wako Chemicals USA, Inc. | 05/07/1997SE |
| K963939 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 12/18/1996SE |
| K955880 | Direct Bilirubin (DND) Assay, Catalogue Number 209-05CIG · Traditional | Diagnostic Chemicals , Ltd. | 08/27/1996SE |
| K955940 | Total Bilirubin ReagentCIG · Traditional | Derma Media Lab., Inc. | 03/13/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 12/20/1995SE |
| K942999 | Bilirubin(Total) QvetCIG · Traditional | Prisma Systems | 12/02/1994SE |
| K942949 | Bilirubin (Direct) QvetCIG · Traditional | Prisma Systems | 11/22/1994SE |
| K934068 | Beckman Direct Bilirubin ReagentCIG · Traditional | Beckman-Diagnostic Systems Group | 04/26/1994SE |
| K940570 | Synermed Total Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 04/20/1994SE |
| K933026 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 10/28/1993SE |
| K932159 | Systemate Direct Bilirubin Cat. No. 65406CIG · Traditional | Em Diagnostic Systems, Inc. | 09/21/1993SE |
| K931888 | Total BilirubinCIG · Traditional | Em Diagnostic Systems, Inc. | 07/27/1993SE |
| K930679 | Direct BilirubinCIG · Traditional | Horizon Diagnostics, Inc. | 06/29/1993SE |
| K924964 | Olympus Total Bilirubin ReagentCIG · Traditional | Olympus Corp. | 12/03/1992SE |
| K924963 | Olympus Direct Bilirubin ReagentCIG · Traditional | Olympus Corp. | 11/30/1992SE |
| K923609 | Olympus Total Bilirubin ReagentCIG · Traditional | Olympus Corp. | 10/02/1992SE |
| K923083 | Total Bilirubin Catalog No. 65407CIG · Traditional | Em Diagnostic Systems, Inc. | 09/09/1992SE |
| K922856 | Systemate Direct Bilirubin Test Technicon Ra 1000CIG · Traditional | Em Diagnostic Systems, Inc. | 09/09/1992SE |
| K923608 | Olympus Direct Bilirubin ReagentCIG · Traditional | Olympus Corp. | 08/18/1992SE |
| K920653 | Il Test Bilirubin Total/DirectCIG · Traditional | Instrumentation Laboratory CO | 07/23/1992SE |
| K921844 | Kodak Ektachem DT Slides (Nbil)CIG · Traditional | Eastman Kodak Company | 07/21/1992SE |
| K914873 | Diazo Colorimetry, BilirubinCIG · Traditional | Pointe Scientific, Inc., | 12/04/1991SE |
| K913466 | Abbott Quickstart Direct Bilirubin (Dbil) #5A20CIG · Traditional | Em Diagnostic Systems, Inc. | 10/25/1991SE |
| K913307 | Abbott Quickstart Total Bilirubin (Tbil) #5A21CIG · Traditional | Em Diagnostic Systems, Inc. | 10/11/1991SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | Amersham Corp. | 07/22/1991SE |
| K911866 | Trace Total/Direct Bilirubin ReagentCIG · Traditional | Trace Scientific , Ltd. | 07/17/1991SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | Biochemical Trade, Inc. | 05/15/1991SE |
| K910593 | Roche Reagent for Direct BilirubinCIG · Traditional | Roche Diagnostic Systems, Inc. | 04/24/1991SE |
| K910591 | Roche Reagent for Total BilirubinCIG · Traditional | Roche Diagnostic Systems, Inc. | 04/24/1991SE |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional | Amresco, Inc. | 01/17/1991SE |
| K905622 | Coulter Direct Billrubin ReagentCIG · Traditional | Coulter Electronics, Inc. | 12/26/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | Amresco, Inc. | 10/12/1990SE |
| K903728 | Synermed Direct Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 09/21/1990SE |
| K902801 | Beckman Total Bilirubin Triggered (Tb-T) KitCIG · Traditional | Beckman Instruments, Inc. | 07/17/1990SE |
| K902328 | Synermed Total Bilirubin Reagent KitCIG · Traditional | Synermed, Inc. | 06/28/1990SE |
| K902199 | Coulter Direct BilirubinCIG · Traditional | Coulter Corp. | 06/12/1990SE |
| K902123 | Systemate(Tm) Direct Bilirubin Catalog No. 65406CIG · Traditional | Em Diagnostic Systems, Inc. | 06/06/1990SE |
| K897174 | Olympus(Tm) Total BilirubinCIG · Traditional | Em Diagnostic Systems, Inc. | 05/10/1990SE |
| K901266 | Coulter Total Bilirubin ReagentCIG · Traditional | Coulter Corp. | 04/25/1990SE |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | American Research Products Co. | 04/16/1990SE |
| K897176 | Systemate(Tm) Total Bilirubin Catalog No. 654XXCIG · Traditional | Em Diagnostic Systems, Inc. | 03/19/1990SE |
| K897175 | Olympus Direct BilirubinCIG · Traditional | Em Diagnostic Systems, Inc. | 03/15/1990SE |
| K900259 | Direct Bilirubin ReagentCIG · Traditional | Medical Analysis Systems, Inc. | 02/27/1990SE |
| K896232 | Cobas Ready Total Bilirubin ReagentCIG · Traditional | Roche Diagnostic Systems, Inc. | 02/27/1990SE |
| K895822 | Total Bilirubin L.F.CIG · Traditional | Sclavo, Inc. | 11/14/1989SE |
| K895119 | Systemate Direct Bilirubin Catalog No. 65406CIG · Traditional | Em Diagnostic Systems, Inc. | 10/17/1989SE |
| K895118 | Systemate Total Bilirubin Catalog No. 65407CIG · Traditional | Em Diagnostic Systems, Inc. | 10/17/1989SE |
| K892801 | Clinistat Total Bilirubin Reagent TestCIG · Traditional | Heraeus Kulzer, Inc. | 08/15/1989SE |
| K893730 | Direct Bilirubin ReagentCIG · Traditional | Medical Analysis Systems, Inc. | 08/11/1989SE |
| K892668 | Total Bilirubin for Manual/Automated ApplicationsCIG · Traditional | Catachem, Inc. | 07/20/1989SE |
| K892905 | Direct Bilirubin for Manual or Automated Appli.CIG · Traditional | Catachem, Inc. | 06/19/1989SE |
| K891240 | Direct Bilirubin for Continuous FlowCIG · Traditional | Catachem, Inc. | 05/10/1989SE |
| K891025 | Total Bilirubin for Continuous FlowCIG · Traditional | Catachem, Inc. | 04/04/1989SE |
| K890070 | Total Bilirubin Reagent, ConcentratedCIG · Traditional | Trace Scientific , Ltd. | 03/06/1989SE |
| K885285 | Direct Bilirubin Test Catalog No. SR1008CIG · Traditional | Em Diagnostic Systems, Inc. | 01/30/1989SE |
| K885284 | Total Bilirubin Test Catalog No. SR1007CIG · Traditional | Em Diagnostic Systems, Inc. | 01/30/1989SE |
| K871115 | Ub Analyzer, Model UA-1/REAGENT Kit/Bilirubin Con.CIG · Traditional | Labo Science-USA, Inc. | 01/27/1989SE |
| K884224 | Total Bilirubin Reagent Kit for Astra SystemsCIG · Traditional | A-Kem, Inc. | 12/15/1988SE |
| K880437 | Vision(R) Total Bilirubin with a Neonatal ClaimCIG · Traditional | Abbott Laboratories | 08/03/1988SE |
| K882459 | Diazo, Colorimetric BilirubinCIG · Traditional | Tech-Neal Scientific, Inc. | 08/02/1988SE |
| K881798 | Technicon Chem 1(R) System, Direct BilirubinCIG · Traditional | Technicon Instruments Corp. | 06/07/1988SE |
| K881172 | Bilirubin (Direct)CIG · Traditional | Tech-Co, Inc. | 06/07/1988SE |
| K881241 | Total Bilirubin ReagentCIG · Traditional | Tech-Neal Scientific, Inc. | 05/27/1988SE |
| K881166 | Direct Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 04/28/1988SE |
| K880743 | Abbott A-Gent Neonatal Bilirubin ReagentCIG · Traditional | Abbott Laboratories | 04/05/1988SE |
| K880397 | Direct Bilirubin Procedure Run on a AU5000 Instru.CIG · Traditional | Data Medical Associates, Inc. | 03/15/1988SE |
| K880396 | Total Bilirubin Procedure Run on a AU5000 Instru.CIG · Traditional | Data Medical Associates, Inc. | 03/15/1988SE |
| K880395 | Total Bilirubin Procedure Run on a Demand Instru.CIG · Traditional | Data Medical Associates, Inc. | 03/15/1988SE |
| K875069 | Bilirubin (Total)CIG · Traditional | Tech-Co, Inc. | 01/11/1988SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | Simmler, Inc. | 11/25/1987SE |
| K874261 | Iq/Qca Total BilirubinCIG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/25/1987SE |
| K872818 | Reflotron BilirubinCIG · Traditional | Boehringer Mannheim Corp. | 11/23/1987SE |
| K873551 | Conjugated Bilirubin (Cbil) Item No. 67684/95CIG · Traditional | Em Diagnostic Systems, Inc. | 10/02/1987SE |
| K873424 | Easy-Test Conjugated Bilirubin (Cbil) #16690CIG · Traditional | Em Diagnostic Systems, Inc. | 09/14/1987SE |
| K872513 | Easy-Test Total Bilirubin (Tbil) Item No. 16604CIG · Traditional | Em Diagnostic Systems, Inc. | 08/21/1987SE |
| K872512 | Emds Total Bilirubin (Tbil) Testpacks, #67675/95CIG · Traditional | Em Diagnostic Systems, Inc. | 08/21/1987SE |
| K872487 | Vision(R) Total BilirubinCIG · Traditional | Abbott Laboratories | 08/21/1987SE |
| K870365 | Direct Bilirubin Reagent - Acid Diazo MethodCIG · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K870364 | Total Bilirubin Reagent - Dmso MethodCIG · Traditional | Trace Scientific , Ltd. | 08/19/1987SE |
| K872197 | Procedure No. 552/553 Bilirubin, Total and DirectCIG · Traditional | Sigma Diagnostics, Inc. | 08/13/1987SE |
| K870095 | Bilirubin TesterCIG · Traditional | Wako Chemicals USA, Inc. | 06/03/1987SE |
| K871531 | Reagents 1263,1273,1284,1425,014301,053583CIG · Traditional | American Research Products Co. | 05/18/1987SE |
| K871530 | Total Bilirubin Reagent 1372,1425,1284,1273,053583CIG · Traditional | American Research Products Co. | 05/14/1987SE |
| K863056 | Bilirubin TotalCIG · Traditional | J. D. Assoc. | 11/24/1986SE |
| K863265 | Direct Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 10/24/1986SE |
| K863057 | Bilirubin Total DirectCIG · Traditional | J. D. Assoc. | 09/26/1986SE |
| K863262 | Total Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 09/17/1986SE |
| K863055 | BilifastCIG · Traditional | J. D. Assoc. | 09/09/1986SE |
| K862359 | Meth./Cali./Intru. Check for the Dimension SystemCIG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/19/1986SE |
| K862299 | Amresco Flow Pac Total Bilirubin ReagentsCIG · Traditional | Amresco, Inc. | 07/01/1986SE |
| K861998 | Total Bilirubin Test KitCIG · Traditional | Ciba Corning Diagnostics Corp. | 06/27/1986SE |
| K861671 | Direct Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 06/25/1986SE |
| K861651 | Total Bilirubin ProcedureCIG · Traditional | Data Medical Associates, Inc. | 05/29/1986SE |
| K861413 | Bilirubin*Sr (Total) Liquid Stable Reagent SetCIG · Traditional | Medical Analysis Systems, Inc. | 04/24/1986SE |
| K861095 | Bilirubin Assay Kit (Total), Cata. Number 202-04CIG · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 04/21/1986SE |
| K861094 | Bilirubin Assay Kit (Direct), Cata. Number 202-02CIG · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 04/21/1986SE |
| K860424 | A-Gent Liquid Total BilirubinCIG · Traditional | Abbott Laboratories | 04/03/1986SE |
| K860214 | Total Bilirubin Reagent SetCIG · Traditional | Sterling Diagnostics, Inc. | 03/17/1986SE |
| K855079 | Neonatal Bilirubin(Nbil) Test Pack 67661/95CIG · Traditional | Em Diagnostic Systems, Inc. | 03/05/1986SE |
| K860257 | Direct BilirubinCIG · Traditional | Pointe Scientific, Inc., | 02/21/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | Technostics Intl. | 01/14/1986SE |
| K854180 | In-Vitro Test Determination Total BilirubinCIG · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K852008 | T-Bil Reagent, D-Bil Reagent, Sodium Nitrite & SulCIG · Traditional | Alpkem Corp. | 05/30/1985SE |
| K850748 | I-L Test, Direct Bilirubin SetCIG · Traditional | Allied Instrumentation Laboratory | 04/03/1985SE |
| K843908 | Abbott TDT EiaCIG · Traditional | Abbott Laboratories | 04/03/1985SE |
| K850901 | Data Chem Auto-Bilirubin/Direct ProcedureCIG · Traditional | Data Medical Associates, Inc. | 04/01/1985SE |
| K850379 | Direct Bilirubin for Demand AnalyzerCIG · Traditional | Advanced Biomedical Methods, Inc. | 03/01/1985SE |
| K843329 | Systemate D-Bili 67213CIG · Traditional | Em Diagnostic Systems, Inc. | 09/20/1984SE |
| K843328 | Systemate T-Bili 67212CIG · Traditional | Em Diagnostic Systems, Inc. | 09/20/1984SE |
| K843178 | Total Bilirubin TestCIG · Traditional | Sclavo, Inc. | 09/07/1984SE |
| K843032 | Bilirubin Assay Kit - TotalCIG · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/04/1984SE |
| K843027 | Bilirubin Assay Kit DirectCIG · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/04/1984SE |
| K842809 | Technicon RA-1000 Sys, Direct BilirubinCIG · Traditional | Technicon Instruments Corp. | 08/17/1984SE |
| K842385 | Aca Conjugated Bilirubin AnalyticalCIG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/17/1984SE |
| K841892 | Raichem Bilirubin Reagent Total/DirectCIG · Traditional | Reagents Applications, Inc. | 06/07/1984SE |
| K840757 | Elvi 444 BilitronCIG · Traditional | Logos Scientific, Inc. | 05/30/1984SE |
| K841572 | Direct Bilirubin ReagentCIG · Traditional | Hi Chem, Inc. | 05/16/1984SE |
| K841050 | Total Bilirubin Reagent SetCIG · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K840486 | Total Bilirubin ReagentCIG · Traditional | Somas Medical Industries, Inc. | 04/25/1984SE |
| K840880 | Ektachem Clinical Chem. SlidesCIG · Traditional | Eastman Kodak Company | 04/18/1984SE |
| K840779 | Neonatal Bilirubin ReagentCIG · Traditional | American Dade | 04/13/1984SE |
| K840777 | Direct Bilirubin ReagentCIG · Traditional | American Dade | 04/05/1984SE |
| K840606 | Ektachem Clinical Chem. SlidesCIG · Traditional | Eastman Kodak Company | 04/04/1984SE |
| K840111 | Total BilirubinCIG · Traditional | Fisher Scientific Co., LLC | 03/19/1984SE |
| K840564 | Liqui Zyme Total Bilirubin ReagentCIG · Traditional | American Research Products Co. | 03/09/1984SE |
| K832942 | Total & Direct Bilirubin ProceduresCIG · Traditional | Sandare Chemical Co., Inc. | 11/07/1983SE |
| K833004 | Paramax Total Bilirubin ReagentCIG · Traditional | American Dade | 10/14/1983SE |
| K832748 | Compur* Easytouch Total BilirubinCIG · Traditional | Worthington Diagnostic Systems | 10/14/1983SE |
| K832870 | Diazo Colorimetry, BillirubinCIG · Traditional | Pointe Scientific, Inc., | 09/26/1983SE |
| K832357 | Aca Total Bilirubin Analytical Test PakCIG · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/01/1983SE |
| K832236 | Sigma Procedure #550 Determ. BilirubCIG · Traditional | Sigma Chemical Co. | 08/31/1983SE |
| K831844 | Direct Bilirubin ReagentCIG · Traditional | Gilford Diagnostics | 07/18/1983SE |
| K831843 | Gilchem Total Bilirubin ReagentCIG · Traditional | Gilford Diagnostics | 07/18/1983SE |
| K830714 | Total Bilirubin ReagentCIG · Traditional | Hi Chem, Inc. | 04/06/1983SE |
| K821873 | Ultrachem T-BiliCIG · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K821197 | Total Bilirubin Reagent SetCIG · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K821462 | Ultrachem T-Bili, #64971CIG · Traditional | Emd Chemicals, Inc. | 06/01/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3065-2024 Class II | Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number…During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were… | Siemens Healthcare Diagnostics, Inc. | 07/30/2024Open, Classified |
| Z-2623-2023 Class II | VITROS XT Chemistry Products TBIL-ALKP SlidesSamples containing high levels of ALKP (or an interfering substance) could deplete the available substrate… | Ortho-Clinical Diagnostics, INc. | 08/05/2023Open, Classified |
| Z-2875-2020 Class II | VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | Ortho-Clinical Diagnostics | 07/13/2020Terminated |
| Z-2874-2020 Class II | VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | Ortho-Clinical Diagnostics | 07/13/2020Terminated |
| Z-1541-2020 Class II | Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Siemens Healthcare Diagnostics, Inc. | 02/13/2020Terminated |
| Z-1540-2020 Class II | Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | Siemens Healthcare Diagnostics, Inc. | 02/13/2020Terminated |
| Z-0153-2020 Class III | Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test…Due to low Quality Control recovery and invalid Calibration. | Roche Diagnostics Operations, Inc. | 09/11/2019Terminated |
| Z-1426-2020 Class II | Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | Beckman Coulter Inc | 08/15/2019Terminated |
| Z-1425-2020 Class II | Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200…It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen… | Beckman Coulter Inc | 08/15/2019Terminated |
| Z-1145-2019 Class II | Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160…New endogenous interference claims have been established for the following assays used on the cobas c 311… | Roche Diagnostics Corporation | 12/17/2018Terminated |
| Z-1654-2018 Class II | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | Siemens Healthcare Diagnostics, Inc. | 06/29/2017Terminated |
| Z-1226-2014 Class II | VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF)…An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that… | Ortho-Clinical Diagnostics | 01/09/2014Terminated |
| Z-0365-2014 Class II | Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2…Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots… | Siemens Healthcare Diagnostics | 09/24/2013Terminated |
| Z-0324-2014 Class II | VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0300-2014 Class II | VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-2586-2017 Class II | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry…Decrease reactivity of R 1 component. | Medtest Holdings, Inc. | 03/13/2012Terminated |
| Z-1014-2010 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI.…R2 reagent component may fail because it may contain R1 reagent. The reagent was rendered inoperative and… | Pointe Scientific, Inc. | 07/29/2009Terminated |
| Z-1425-2012 | Clinical Chemistry Total Bilirubin, 6L45-20 and 6L45-40. Used for the quantitative…Abbott Laboratories has issued a recall on the Clinical Chemistry Total Bilirubin due to an under-recovery… | Abbott Laboratories Inc. | 07/09/2009Terminated |
| Z-1202-2009 | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The…The product performance fails due to precipitation of the R2 component. | Pointe Scientific, Inc. | 02/02/2009Terminated |