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EliA Rib-P Well
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 14-5521-01
by Phadia AB
Identity
- Trade Name
- EliA Rib-P Well EUDAMEDFDA UDI
- Generic Name
- Ribosomal phosphoprotein antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA Rib-P EUDAMEDEliA Rib-P Well FDA UDI
- Model / Reference
- 14-5521-01 EUDAMEDDECC055210 FDA UDI
- Description
- EliA Rib-P Well FDA UDI
Identifiers
- Catalog Number
- DECC055210 FDA UDI
- Primary DI / UDI-DI
- 07333066015538 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0087ML EUDAMED
- FDA Product Code
- MQA FDA UDI
- EMDN Code
- W0102100118 RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES EUDAMED
- GMDN Term
- Ribosomal phosphoprotein antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5100 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
EliA Rib-P Well 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 | K202540 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0087ML | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (3)
- EUDAMED f46b4229-ac5b-4df9-b007-005e61dbbebb 61 fields · synced Jul 9, 2026
- FDA UDI 0760e907-59ea-4136-a3ff-1549cb3c583b 36 fields · synced May 29, 2026
- FDA 510(k) K202540 1 fields · synced May 18, 2026