An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bil
| Company | Devices | Share |
|---|---|---|
| Arkray Usa, Inc. | 16 | 27% |
| Beckman Coulter Ireland Inc. | 8 | 14% |
| Urit Medical Electronic Co., Ltd. | 7 | 12% |
| Mckesson Medical-Surgical Inc. | 6 | 10% |
| Roche Diagnostics Gmbh | 3 | 5% |
| Stanbio Laboratory, L.P. | 3 | 5% |
| Siemens Healthcare Diagnostics Inc. | 3 | 5% |
| Alifax Srl | 3 | 5% |
| Biobase Biodustry(Shandong)Co., Ltd. | 2 | 3% |
| Kunming Lianen Biotechnology Co., Ltd | 1 | 2% |
| Contec Medical Systems Co., Ltd. | 1 | 2% |
| Sysmex Corporation | 1 | 2% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| KQO | Automated Urinalysis System | 32 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 22 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 17 |
| JIO | Blood, Occult, Colorimetric, In Urine | 16 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 15 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 15 |
Use these as the dimensions to specify in a tender line.
59 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urine analyser IVD, laboratory", from 17 companies. The largest labeler is Arkray Usa, Inc. with 27% of records.
KQO (Automated Urinalysis System), JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)), JIO (Blood, Occult, Colorimetric, In Urine)
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.