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ImmunoCAP Specific IgE Control L
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 10-9528-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Specific IgE Control L EUDAMEDFDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- ImmunoCAP Specific IgE EUDAMEDImmunoCAP Specific IgE Control L FDA UDI
- Model / Reference
- 10-9528-01 EUDAMED34-2341-11 FDA UDI
- Description
- ImmunoCAP Specific IgE Control L FDA UDI
Identifiers
- Catalog Number
- 34-2341-11 FDA UDI
- Primary DI / UDI-DI
- 07333066019949 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0004LN EUDAMED
- 510(k) Number
- K131738 FDA UDI
- FDA Product Code
- DHB FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Plasma protein IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ImmunoCAP Specific IgE Control L by Phadia AB — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131738 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0004LN | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (3)
- EUDAMED b2df14a7-0917-4888-8f31-3aa61ba33b1d 61 fields · synced Jul 12, 2026
- FDA UDI 88faccf7-d1ea-46a8-902f-474f1b75da7e 37 fields · synced May 30, 2026
- FDA 510(k) K131738 1 fields · synced May 18, 2026