A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.
| Company | Devices | Share |
|---|---|---|
| Phadia Ab | 574 | 98% |
| Hycor Biomedical Llc | 12 | 2% |
| Drg Instruments Gesellschaft Mit Beschränkter Haftung | 1 | 0% |
| Drg International Inc | 1 | 0% |
Company = labeler of record on GUDID. 4 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 |
|---|---|---|
| DHB | SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL | 370 |
| MVU | Reagents, specific, analyte | 179 |
| DHB | System, test, radioallergosorbent (rast) immunological | 15 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 14 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Us | 13 |
| PUW | System, test, radioallergosorbent (Rast) immunological, exem | 10 |
Use these as the dimensions to specify in a tender line.
588 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)", from 4 companies. The largest labeler is Phadia Ab with 98% of records.
DHB (SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL), MVU (Reagents, specific, analyte), DHB (System, test, radioallergosorbent (rast) immunological), DHB (System, Test, Radioallergosorbent (Rast) Immunological)
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.