A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorime
| Company | Devices | Share |
|---|---|---|
| Acon Laboratories, Inc. | 63 | 26% |
| Teco Diagnostics | 44 | 18% |
| Siemens Healthcare Diagnostics Inc. | 18 | 7% |
| Dfi Co.,Ltd | 12 | 5% |
| Safecare Biotech (Hangzhou) Co., Ltd. | 11 | 5% |
| Urit Medical Electronic Co., Ltd. | 10 | 4% |
| Roche Diagnostics Gmbh | 10 | 4% |
| Yd Diagnostics Corp. | 10 | 4% |
| Henry Schein, Inc. | 9 | 4% |
| Germaine Laboratories, Inc | 6 | 2% |
| Cardinal Health 200, Llc | 5 | 2% |
| Medline Industries, Inc. | 5 | 2% |
Company = labeler of record on GUDID. 31 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 |
|---|---|---|
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 85 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 84 |
| JIL | METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) | 82 |
| JIR | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | 78 |
| LJX | Test, Urine Leukocyte | 68 |
| JMT | DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) | 65 |
Use these as the dimensions to specify in a tender line.
243 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple urine analyte IVD, kit, rapid colorimetric, clinical", from 31 companies. The largest labeler is Acon Laboratories, Inc. with 26% of records.
JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), JIL (METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)), JIR (INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.))
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.