Identity
- Trade Name
- GIARDIA II FDA UDI
- Generic Name
- Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FDA UDI
- Model / Reference
- 30405 FDA UDI
- Description
- The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002028 FDA UDI
- 510(k) Number
- K033274 FDA UDI
- FDA Product Code
- MHI FDA UDI
- GMDN Term
- Giardia lamblia 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
Yes
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: Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA)
Giardia Ii by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Giardia lamblia antigen IVD, kit, enzyme immunoassay (EIA).
- EZ-GIARDIA One-Step Giardia Test — BIOMERICA, INC. · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC. · Class II
- GIARDIA II — TECHLAB, INC. · Class II
Cleared under the same submission
K033274 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 1ac76716-ed9a-4c6e-8c3e-db8b5e8c6107 34 fields · synced May 30, 2026