Identity
- Trade Name
- EliA Sm Well FDA UDI
- Generic Name
- Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA Sm Well FDA UDI
- Model / Reference
- DECC055020 FDA UDI
- Description
- EliA Sm Well FDA UDI
Identifiers
- Catalog Number
- DECC055020 FDA UDI
- Primary DI / UDI-DI
- 07333066014531 FDA UDI
- FDA Product Code
- LKJ FDA UDI
- GMDN Term
- Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay
EliA Sm Well by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Smith antibody (anti-Sm) IVD, kit, fluorescent immunoassay.
- EliA SmDP Well — Phadia GmbH · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI 99e62039-fcfc-45a5-b9ad-0a98d7711144 36 fields · synced Jun 1, 2026