A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.
| Company | Devices | Share |
|---|---|---|
| Horiba Instruments Incorporated | 13 | 20% |
| Roche Diagnostics Gmbh | 12 | 18% |
| Abbott Gmbh | 6 | 9% |
| Beckman Coulter, Inc. | 6 | 9% |
| Siemens Healthcare Diagnostics Inc. | 5 | 8% |
| Carolina Liquid Chemistries Corporation | 5 | 8% |
| Vitalscientific | 4 | 6% |
| Abbott Ireland | 3 | 5% |
| Horiba Abx Sas | 2 | 3% |
| Stanbio Laboratory, L.P. | 2 | 3% |
| Abbott Laboratories | 2 | 3% |
| Randox Laboratories Limited | 1 | 2% |
Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| CIG | DIAZO COLORIMETRY, BILIRUBIN | 40 |
| CIG | Diazo Colorimetry, Bilirubin | 28 |
| MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM | 14 |
| JFM | ENZYMATIC METHOD, BILIRUBIN | 3 |
| JFM | Enzymatic Method, Bilirubin | 2 |
Use these as the dimensions to specify in a tender line.
65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total bilirubin IVD, kit, spectrophotometry", from 16 companies. The largest labeler is Horiba Instruments Incorporated with 20% of records.
CIG (DIAZO COLORIMETRY, BILIRUBIN), CIG (Diazo Colorimetry, Bilirubin), MQM (BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM), JFM (ENZYMATIC METHOD, BILIRUBIN)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.