CIG · Diazo Colorimetry, Bilirubin
Clinical Chemistry · 21 CFR 862.1110 · Class 2
Overview
| Product Code | CIG |
|---|---|
| Device Name | Diazo Colorimetry, Bilirubin |
| Regulation | 21 CFR 862.1110 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 235)
Showing 20 most recent of 235 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | Feb 27, 2026 | SESE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | Jun 12, 2023 | SESE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | Mar 20, 2023 | SESE |
| K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | Dec 29, 2022 | SESE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | Apr 26, 2019 | SESE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | Elitechgroup | Jul 11, 2017 | SESE |
| K150510 | Total Bilirubin | Abbott Laboratories | Apr 2, 2015 | SESE |
| K131544 | COBAS C BILIRUBIN TOTAL GEN.3 | Roche Diagnostics | Jul 17, 2013 | SESE |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | Hitachi Chemical Diagnostics, Inc. | Jun 7, 2013 | SESE |
| K123802 | EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT | Medica Corp. | Mar 1, 2013 | SESE |
| K123965 | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 | Roche Diagnostics | Feb 28, 2013 | SESE |
| K121985 | ARCHITECT TOTAL BILIRUBIN | Abbott Laboratories | Feb 1, 2013 | SESE |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | Elitechgroup | Oct 7, 2011 | SESE |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | Polymedco, Inc. | Sep 1, 2011 | SESE |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO | Instrumentation Laboratory CO | Jun 18, 2010 | SESE |
| K091991 | EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 | Medica Corp. | Sep 4, 2009 | SESE |
| K081193 | COBAS INTEGRA 400/800 BILIRUBIN TOTAL | Roche Diagnostics | Jan 16, 2009 | SESE |
| K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | Genzyme Diagnostics P.E.I., Inc. | Dec 16, 2008 | SESE |
| K080810 | EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT | Medica Corp. | Dec 10, 2008 | SESE |
| K080435 | OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 | Olympus Life Science Research Europa GmbH (Europa) | Sep 5, 2008 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 21 clearances
- Abbott Laboratories — 15 clearances
- Data Medical Associates, Inc. — 10 clearances
- Synermed, Inc. — 7 clearances
- Harleco — 6 clearances
