Identity
- Trade Name
- Entamoeba histolytica Ag (stool) ELISA FDA UDI
- Generic Name
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces FDA UDI
- Model / Reference
- EIA-3473 FDA UDI
- Description
- This ELISA is an in vitro immunoassay for the qualitative determination of E. histolytica antigen in feces FDA UDI
Identifiers
- Catalog Number
- EIA-3473 FDA UDI
- Primary DI / UDI-DI
- 04048474034738 FDA UDI
- FDA Product Code
- GMO FDA UDI
- GMDN Term
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3220 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Entamoeba histolytica Ag (stool) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID
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 af764d11-8a9d-4c8c-8a16-b5ff614b1bf0 37 fields · synced May 30, 2026