Identity
- Trade Name
- RIDASCREEN® Entamoeba histolytica IgG FDA UDI
- Generic Name
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis. FDA UDI
- Model / Reference
- K1721 FDA UDI
- Description
- The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis. FDA UDI
Identifiers
- Catalog Number
- K1721 FDA UDI
- Primary DI / UDI-DI
- 04049095110023 FDA UDI
- GMDN Term
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RIDASCREEN® Entamoeba histolytica IgG by R-Biopharm AG — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| 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
- R-Biopharm AG
Sources (2)
- FDA UDI 49466845-dd94-48b8-a06c-b6728b8c5009 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026