Identity
- Trade Name
- RELISA® ENA Single Well Screening Test FDA UDI
- Generic Name
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- RELISA® BP- ENA Single Well Screen Test - 576 wells FDA UDI
- Model / Reference
- 7696-10 FDA UDI
- Description
- RELISA® BP- ENA Single Well Screen Test - 576 wells FDA UDI
Identifiers
- Catalog Number
- 7696-10 FDA UDI
- Primary DI / UDI-DI
- M7497696101 FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
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
Yes
FDA UDI
RELISA® ENA Single Well Screening Test by Immuno Concepts Inc — 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).
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA ENA Screen Test Sytem — ZEUS SCIENTIFIC, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- DIASTAT ENA Single Well Screen — Euro-Diagnostica AB · Class II
- DIASTAT ENA Profile — Euro-Diagnostica AB · Class II
- QUANTA Lite® ENA 4 ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® ENA 6 ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® ENA 5 ELISA — INOVA DIAGNOSTICS, 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immuno Concepts Inc
Sources (1)
- FDA UDI c8056bf4-50f8-45e2-95f3-0f884340f33a 34 fields · synced Jun 8, 2026