A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total protein in a clinical specimen.
| Company | Devices | Share |
|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | 24 | 31% |
| Horiba Instruments Incorporated | 12 | 16% |
| Infrared Laboratory Systems Llc | 10 | 13% |
| Drew Scientific, Inc. | 5 | 6% |
| Abbott Ireland | 4 | 5% |
| Medicon Hellas S.A. | 3 | 4% |
| Ortho-Clinical Diagnostics, Inc. | 3 | 4% |
| Teco Diagnostics | 3 | 4% |
| Quantimetrix Corporation | 2 | 3% |
| Abbott Gmbh | 2 | 3% |
| The Binding Site Group Limited | 1 | 1% |
| Alfa Wassermann, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 19 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 |
|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | 54 |
| CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 11 |
| JGP | Lowry (Colorimetric), Total Protein | 7 |
| DFI | Total Spinal-Fluid, Antigen, Antiserum, Control | 1 |
| JGP | LOWRY (COLORIMETRIC), TOTAL PROTEIN | 1 |
Use these as the dimensions to specify in a tender line.
77 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Total protein IVD, reagent", from 19 companies. The largest labeler is Biobase Biodustry(Shandong)Co., Ltd. with 31% of records.
CEK (Biuret (Colorimetric), Total Protein), CEK (BIURET (COLORIMETRIC), TOTAL PROTEIN), JGP (Lowry (Colorimetric), Total Protein), DFI (Total Spinal-Fluid, Antigen, Antiserum, 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.