Identity
- Trade Name
- E. Histolytica IgG ELISA FDA UDI
- Generic Name
- Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma. FDA UDI
- Model / Reference
- EIA-3474 FDA UDI
- Description
- The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3474 FDA UDI
- Primary DI / UDI-DI
- 00840239034748 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
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 11 Milliliter FDA UDITotal Volume — 1 Milliliter FDA UDITotal Volume — 30 Milliliter FDA UDITotal Volume — 25 Milliliter FDA UDI
Category: Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
E. Histolytica IgG ELISA by DRG International, Inc. — 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 Instruments Gesellschaft mit beschränkter Haftung · Class II
- Entamoeba histolytica IgG ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- NovaLisa Entamoeba histolytica IgG — Gold Standard Diagnostics Frankfurt GmbH · Class II
- Entamoeba histolytica IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Entamoeba histolytica IgG 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
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 927a36a2-859d-4ccb-908c-9d3e267c8b7b 36 fields · synced May 30, 2026