Identity
- Trade Name
- GIARDIA/CRYPTOSPORIDIUM CHEK FDA UDI
- Generic Name
- Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. FDA UDI
- Model / Reference
- 30401 FDA UDI
- Description
- The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002127 FDA UDI
- 510(k) Number
- K051929 FDA UDI
- FDA Product Code
- MHJ FDA UDI
- GMDN Term
- Multiple faecal parasite 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: Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Giardia/Cryptosporidium Chek by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA).
- 21-Hydroxylase Autoantibody ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- GIARDIA/CRYPTOSPORIDIUM CHEK — TECHLAB, INC. · Class II
- GIARDIA/CRYPTOSPORIDIUM QUIK CHEK — TECHLAB, INC. · Class II
- TRI-COMBO PARASITE SCREEN — TECHLAB, INC. · Class II
Cleared under the same submission
K051929 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 a99b9f71-9b0e-44de-89e1-3fd2ccd5702e 34 fields · synced Jun 6, 2026