FDA device listing
ImmunoCAP Allergen e227, Allergen Component rEqu c 1, Horse,ImmunoCAP Allergen e228, Allergen Component rFel d 4…
FDA device listing 1271863035 · PHADIA AB
Key facts
| Proprietary names | ImmunoCAP Allergen e227, Allergen Component rEqu c 1, Horse,ImmunoCAP Allergen e228, Allergen Component rFel d 4, Cat,ImmunoCAP Allergen f351, Allergen component rPen a 1, Tropomyosin, Shrimp,ImmunoCAP Allergen f354, Allergen component rBer e 1, Brazil nut,ImmunoCAP Allergen f419, Allergen component rPru p 1, PR-10, Peach,ImmunoCAP Allergen f420, Allergen component rPru p 3, LTP, Peach,ImmunoCAP… |
|---|---|
| Owner/operator | PHADIA AB |
| Owner/operator number | 9004441 |
| Premarket submissions | K113841 |
| 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
- 1–9 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