Identity
- Trade Name
- ENA Screen ELISA FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples. FDA UDI
- Model / Reference
- EIA-3571 FDA UDI
- Description
- ENA Screen ELISA is a test system for the qualitative screening of IgG class autoantibodies against extractable nuclear antigens (ENA): SS-A 60, SS-A 52, SS-B, Sm, RNP/Sm, Scl-70, and Jo-1, in human serum or plasma .samples. FDA UDI
Identifiers
- Catalog Number
- EIA-3571 FDA UDI
- Primary DI / UDI-DI
- 04048474035711 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
ENA Screen ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA).
- Sm IgG ELISA — DRG International, Inc. · Class II
- SSB (La) IgG ELISA — DRG International, Inc. · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
- Anti-SS-B ELISA — DRG International, Inc. · Class II
- Anti-SS-A (Ro) ELISA — DRG International, Inc. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- Anti-Sm ELISA — DRG International, Inc. · Class II
- ENA Screen (entractable nuclear antigen) ELISA — DRG International, Inc. · 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
Sources (1)
- FDA UDI 715dc62b-be56-4673-8dca-2ad9df1cc414 36 fields · synced May 30, 2026