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EliA RNA Pol III Well
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 14-5599-01
by Phadia AB
Identity
- Trade Name
- EliA RNA Pol III Well EUDAMEDFDA UDI
- Generic Name
- RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EliA RNA Pol III EUDAMEDEliA RNA Pol III Well FDA UDI
- Model / Reference
- 14-5599-01 EUDAMEDDECC055990 FDA UDI
- Description
- EliA RNA Pol III Well FDA UDI
Identifiers
- Catalog Number
- DECC055990 FDA UDI
- Primary DI / UDI-DI
- 07333066015583 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0105LV EUDAMED
- FDA Product Code
- NYO FDA UDI
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
- GMDN Term
- RNA polymerase III antibody (anti-Pol III) IVD, kit, enzyme immunoassay (EIA) 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 RNA Pol III 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 | K202541 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 7333066BUDI0105LV | Class B | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (3)
- EUDAMED 2f7386eb-79bd-429c-8de8-e815ab87b502 61 fields · synced Jul 20, 2026
- FDA UDI 2890fba1-424d-433a-936e-5c267593d3da 36 fields · synced May 30, 2026
- FDA 510(k) K202541 1 fields · synced May 18, 2026