Identity
- Trade Name
- NovaLisa Entamoeba histolytica IgG FDA UDI
- Generic Name
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin). FDA UDI
- Model / Reference
- ENTG0140 FDA UDI
- Description
- The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin). FDA UDI
Identifiers
- Catalog Number
- ENTG0140 FDA UDI
- Primary DI / UDI-DI
- ENTIENTG01400 FDA UDI
- FDA Product Code
- KHW 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
- 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
No
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
Category: Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
NovaLisa Entamoeba histolytica IgG by Gold Standard Diagnostics Frankfurt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Entamoeba histolytica IgG ELISA — DRG International, Inc. · Class II
- Entamoeba histolytica IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Entamoeba histolytica IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- E. Histolytica IgG ELISA — DRG International, Inc. · Class II
- Entamoeba histolytica IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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
- Manufacturer
- Gold Standard Diagnostics Frankfurt GmbH
Sources (1)
- FDA UDI 0fa5897b-3fe3-4487-b005-6be28f94f8dd 36 fields · synced Jun 6, 2026