FDA device listing
ImmunoCAP Allergen d203, Allergen component rDer p 2, House dust mite,ImmunoCAP Allergen d205, Allergen component rDer p…
FDA device listing 1762348878 · PHADIA AB
Key facts
| Proprietary names | ImmunoCAP Allergen d203, Allergen component rDer p 2, House dust mite,ImmunoCAP Allergen d205, Allergen component rDer p 10 Tropomyosin, House dust mite,ImmunoCAP Allergen e220, Allergen component rFel d 2 Cat serum albumin,ImmunoCAP Allergen e94, Allergen component rFel d 1 Cat,ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut,ImmunoCAP Allergen f422, Allergen component rAra h 1… |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K101251 |
| Product codes | DHB |
| Device names | DHB - System, Test, Radioallergosorbent (Rast) Immunological |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5750 |
| Review panels | Immunology |
| Registered establishments | PHADIA AB, PHADIA US INC. |
| Establishment registrations | 9610566, 3004973408, 3039353646 |
| FEI numbers | 3002807876, 3004973408, 3039353646 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database