A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.
| Company | Devices | Share |
|---|---|---|
| Kova International, Inc. | 60 | 65% |
| Lgc Clinical Diagnostics, Inc. | 12 | 13% |
| Quantimetrix Corporation | 9 | 10% |
| Mckesson Medical-Surgical Inc. | 8 | 9% |
| Streck, Inc. | 3 | 3% |
Company = labeler of record on GUDID. 5 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 |
|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | 82 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 11 |
| JPK | Mixture, Hematology Quality Control | 2 |
Use these as the dimensions to specify in a tender line.
92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urine sediment IVD, control", from 5 companies. The largest labeler is Kova International, Inc. with 65% of records.
JJW (Urinalysis Controls (Assayed And Unassayed)), JJY (Multi-Analyte Controls, All Kinds (Assayed)), JPK (Mixture, Hematology Quality Control)
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.