FDA Registration
Active
🇺🇸 United States
ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
Reg #: 3004973408
·
FEI: 3004973408
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PHADIA US INC.
- Registration Number
- 3004973408
- FEI Number
- 3004973408
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4169 COMMERCIAL AVE.
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
Owner / Operator
- Firm Name
- PHADIA AB
- Operator Number
- 9004441
- Address
- Rapsgatan 7P, P.O. Box 6460
- City
- UPPSALA
- State
- SE-C
- Postal Code
- 75137
- Country
- SE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | PUW | Class 2 | Immunology | No | 2019-05-20 |
Proprietary Names
ImmunoCAP Allergen i214, Allergen component rApi m 2, Honey bee
ImmunoCAP Allergen i211, Allergen component rVes v 1 Phospholipase A1 Common wasp
ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee
ImmunoCAP Allergen Component MUXF3 CCD, Bromelain
ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
ImmunoCAP Allergen i209, Allergen component rVes v 5 Common wasp
ImmunoCAP Allergen i210, Allergen component rPol d 5 European Paper wasp
ImmunoCAP Allergen i208, Allergen component rApi m 1 Phospholipase A2 Honeybee
ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
ImmunoCAP Allergen f98, Gliadin
Establishment Types
Complaint File Establishment per 21 CFR 820.198