One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin mo
| Company | Devices | Share |
|---|---|---|
| Becton, Dickinson And Company | 24 | 44% |
| Euroimmun Medizinische Labordiagnostika Ag | 10 | 18% |
| Biobase Biodustry(Shandong)Co., Ltd. | 8 | 15% |
| Immco Diagnostics, Inc. | 5 | 9% |
| Immuno Concepts Inc | 3 | 5% |
| Zeus Scientific, Inc. | 2 | 4% |
| Sakura Finetek U.S.A., Inc. | 2 | 4% |
| Ventana Medical Systems, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| MVU | Reagents, specific, analyte | 24 |
| PPM | General Purpose Reagent | 10 |
| KTO | Reagent, Immunoassay, Igg | 8 |
| LKJ | Antinuclear Antibody, Antigen, Control | 3 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
Use these as the dimensions to specify in a tender line.
55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD", from 8 companies. The largest labeler is Becton, Dickinson And Company with 44% of records.
MVU (Reagents, specific, analyte), PPM (General Purpose Reagent), KTO (Reagent, Immunoassay, Igg), LKJ (Antinuclear Antibody, Antigen, 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.