Identity
- Trade Name
- E. HISTOLYTICA II FDA UDI
- Generic Name
- Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test. FDA UDI
- Model / Reference
- 30404 FDA UDI
- Description
- The E. HISTOLYTICA II™ test is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002011 FDA UDI
- 510(k) Number
- K994101 FDA UDI
- FDA Product Code
- KHW 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
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
No
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 Ii by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA).
- E.histolytica Antibody 96Tests — Scimedx Corp. · Class II
- E.histolytica Antibody 96 Test with Calibrator — Scimedx Corp. · Class II
- E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC. · Class II
- E. HISTOLYTICA II — TECHLAB, INC. · Class II
- E. HISTOLYTICA QUIK CHEK — TECHLAB, INC. · Class II
Cleared under the same submission
K994101 also covers:
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
- Techlab, Inc.
Sources (1)
- FDA UDI b8187557-ddd1-431b-8471-f3f5702719d8 34 fields · synced May 30, 2026