Identity
- Trade Name
- E.histolytica Antibody 96Tests FDA UDI
- Generic Name
- Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EH-96 FDA UDI
Identifiers
- Catalog Number
- EH-96 FDA UDI
- Primary DI / UDI-DI
- 00813545025397 FDA UDI
- FDA Product Code
- GWD FDA UDI
- GMDN Term
- Entamoeba histolytica antigen 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
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
Category: Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA)
E.histolytica Antibody 96Tests by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- E.histolytica Antibody 96 Test with Calibrator — Scimedx Corp. · 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
- Scimedx Corp.
Sources (1)
- FDA UDI abe9bfb0-688e-47c7-b7e7-f6d3332590c6 34 fields · synced May 30, 2026