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 qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical spe
| Company | Devices | Share |
|---|---|---|
| Siemens Healthcare Diagnostics Products Ltd | 312 | 67% |
| Hycor Biomedical Llc | 150 | 32% |
| Helena Laboratories Corporation | 3 | 1% |
| R-Biopharm Ag | 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 | 307 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 155 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Us | 89 |
| PUW | System, Test, Radioallergosorbent (Rast) Immunological, Exem | 62 |
| DGC | Ige, Antigen, Antiserum, Control | 40 |
| DHB | System, test, radioallergosorbent (rast) immunological | 7 |
Use these as the dimensions to specify in a tender line.
466 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, reagent", from 4 companies. The largest labeler is Siemens Healthcare Diagnostics Products Ltd with 67% of records.
DHB (SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL), DHB (System, Test, Radioallergosorbent (Rast) Immunological), JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Us), PUW (System, Test, Radioallergosorbent (Rast) Immunological, Exem)
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.
Add allergen-specific immunoglobulin e (ige) antibody ivd, reagent to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
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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.