Product code CIG
- Device name
- Diazo Colorimetry, Bilirubin
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1110
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022-12-29 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Elitechgroup | 2017-07-11 |
| K150510 | Total Bilirubin | Abbott Laboratories | 2015-04-02 |
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 | Roche Diagnostics | 2013-07-17 |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Medica Corp. | 2013-03-01 |
| K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | Roche Diagnostics | 2013-02-28 |
| K121985 | ARCHITECT TOTAL BILIRUBIN | Abbott Laboratories | 2013-02-01 |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | Elitechgroup | 2011-10-07 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | 2011-09-01 |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | Instrumentation Laboratory CO | 2010-06-18 |
| K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 | Medica Corp. | 2009-09-04 |
| K081193 | COBAS INTEGRA 400/800 BILIRUBIN TOTAL | Roche Diagnostics | 2009-01-16 |
| K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | Genzyme Diagnostics P.E.I., Inc. | 2008-12-16 |
| K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT | Medica Corp. | 2008-12-10 |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-05 |
| K063744 | COBAS INTEGRA C 111 | Rochdiag | 2007-01-17 |
| K063543 | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 | Roche Diagnostics Corp. | 2006-12-22 |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nova Biomedical Corp. | 2006-11-01 |
| K061839 | DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 | Dade Behring, Inc. | 2006-08-29 |
| K061719 | DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 | Dade Behring, Inc. | 2006-08-25 |
| K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P | Horiba Abx | 2006-08-16 |
| K060574 | TOTAL BILIRUBIN | Abbott Laboratories | 2006-05-03 |
| K060628 | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR | Dade Behring, Inc. | 2006-04-06 |
| K050869 | MODIFICATION TO ABL800 FLEX | Radiometer Medical Aps | 2005-08-11 |
| K051432 | SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS | Arkray, Inc. | 2005-06-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414614922 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics Inc. | 2024-10-16 |
| 00630414614755 | Atellica CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics Inc. | 2024-10-16 |
| 00380740167585 | Alinity | ABBOTT IRELAND | 2024-08-15 |
| 00380740167561 | ARCHITECT | ABBOTT IRELAND | 2024-08-15 |
| 00850053916045 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-08 |
| 00852169008324 | ClearChem Diagnostics Inc. Direct Bilirubin | CLEARCHEM DIAGNOSTICS INC. | 2023-01-20 |
| 00852169008317 | ClearChem Diagnostics Inc. Total Bilirubin | CLEARCHEM DIAGNOSTICS INC. | 2023-01-20 |
| 00842768014192 | Dimension® Flex® reagent cartridge URCA | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 10758750031801 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2019-11-13 |
| 00380740129033 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 00842768005695 | Dimension® Flex® reagent cartridge TU | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00816068020030 | Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020122 | Advanced Instruments BR2 Hydrochloric Acid | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020023 | Advanced Instruments BR2 Disposable Cuvettes | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020047 | Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020054 | Advanced Instruments BR2 Bilirubin Stat-Analyzer | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020078 | Advanced Instruments BR2 Sample Diluent | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020085 | Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020092 | Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020108 | Advanced Instruments BR2 Sodium Nitrite | Advanced Instruments, LLC | 2016-09-23 |
| 00816068020115 | Advanced Instruments BR2 Sulfanilic Acid | Advanced Instruments, LLC | 2016-09-23 |
| 00385480381857 | Stat Profile | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480380430 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480375559 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480374132 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480369213 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480382977 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480387323 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480400947 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00380740016524 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |