FDA Device Establishments · JSON-LD · Markdown
FEI 3002807876 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3002807876 |
|---|---|
| Owner / Operator | PHADIA AB (#9004441) |
| Address | RAPSGATAN 7P, UPPSALA, SE-751 37, SE |
| Mandatory US Agent | Phadia US Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | DHB |
| Regulation § (21 CFR) | 866.5750 |
| Proprietary names | ImmunoCAP Allergen t224, Allergen component rOle e 1, Olive; ImmunoCAP Allergen e102, Allergen Component rCan f 2, Dog; ImmunoCAP Allergen f432, Allergen component nGly m 6 Glycinin, Soy; ImmunoCAP Allergen t227, Allergen component nOle e 7 LTP, Olive; ImmunoCAP Allergen e226, Allergen component rCan f 5, Dog; ImmunoCAP Allergen e101, Allergen Component rCan f 1, Dog; ImmunoCAP Allergen f353, Allergen component rGly m 4 PR-10, Soy; ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy; ImmunoCAP Allergen e221, Allergen component nCan f 3, Dog serum albumin; ImmunoCAP Allergen t240, Allergen component rOle e 9, Olive |
Source: openFDA. Public-domain (CC0).