A collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.
| Company | Devices | Share |
|---|---|---|
| Helena Laboratories Corporation | 124 | 73% |
| Sebia | 44 | 26% |
| Mardx Diagnostics, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 40 |
| CEF | Electrophoretic, Protein Fractionation | 31 |
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED | 29 |
| CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 20 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 13 |
| JHO | Electrophoretic Separation, Lipoproteins | 8 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
169 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Protein electrophoresis IVD, kit, electrophoresis", from 3 companies. The largest labeler is Helena Laboratories Corporation with 73% of records.
CFF (IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)), CEF (Electrophoretic, Protein Fractionation), LXG (EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED ), CEF (ELECTROPHORETIC, PROTEIN FRACTIONATION)
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.