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ImmunoCAP IgE/ECP/Tryptase Sample Diluent
EUDAMEDFDA UDIClass A (EU MDR)
Ref 10-9360-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP IgE/ECP/Tryptase Sample Diluent EUDAMEDFDA UDI
- Generic Name
- Plasma protein IVD, reagent FDA UDI
- Device Name
- Sample Diluent EUDAMEDImmunoCAP IgE/ECP/Tryptase Sample Diluent FDA UDI
- Model / Reference
- 10-9360-01 EUDAMED34-2275-01 FDA UDI
- Description
- ImmunoCAP IgE/ECP/Tryptase Sample Diluent FDA UDI
Identifiers
- Catalog Number
- 34-2275-01 FDA UDI
- Primary DI / UDI-DI
- 07333066011660 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0003LL EUDAMED
- 510(k) Number
- K133404 FDA UDI
- FDA Product Code
- DGC FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Plasma protein IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5510 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
No
EUDAMED
Animal Tissues
Yes
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 IgE/ECP/Tryptase Sample Diluent by Phadia AB — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0003LL | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED 95c51072-712a-4ea3-a029-bed3e700c1ef 61 fields · synced May 30, 2026
- FDA UDI 085b0ee2-c0ac-4b32-a350-96fcb91a7b91 37 fields · synced May 30, 2026