Identity
- Trade Name
- DIASTAT ENA Profile FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- FAID200 FDA UDI
Identifiers
- Catalog Number
- FAID200 FDA UDI
- Primary DI / UDI-DI
- 07340058410509 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
DIASTAT ENA Profile by Euro-Diagnostica AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA).
- RELISA® ENA Single Well Screening Test — IMMUNO CONCEPTS INC
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- RELISA® ENA Multiparameter Antibody Screening Test — IMMUNO CONCEPTS INC
- ELISA ENA Screen Test Sytem — ZEUS SCIENTIFIC, INC.
- RELISA® ENA Single Well Screening Test — IMMUNO CONCEPTS INC
- RELISA® ENA Multiparameter Antibody Screening Test — IMMUNO CONCEPTS INC
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- RELISA® ENA Multiparameter Antibody Screening Test — IMMUNO CONCEPTS INC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Euro-Diagnostica AB
Sources (1)
- FDA UDI 840836ed-3d27-46b1-9af2-25bf08398a99 33 fields · synced Jun 8, 2026