Identity
- Trade Name
- E. HISTOLYTICA QUIK CHEK FDA UDI
- Generic Name
- Entamoeba histolytica antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The TECHLAB E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history. FOR IN VITRO DIAGNOSTIC USE FDA UDI
- Model / Reference
- T30409 FDA UDI
- Description
- The TECHLAB E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history. FOR IN VITRO DIAGNOSTIC USE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002202 FDA UDI
- 510(k) Number
- K170728 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 Quik Chek 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).
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- E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC. · Class II
- E. HISTOLYTICA II — TECHLAB, INC. · Class II
- E. HISTOLYTICA II — TECHLAB, 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
- Techlab, Inc.
Sources (1)
- FDA UDI c626a193-2d22-4549-b7d0-67f00b842564 34 fields · synced Jun 8, 2026