Identity
- Trade Name
- CRYPTOSPORIDIUM II FDA UDI
- Generic Name
- Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. FDA UDI
- Model / Reference
- 30406 FDA UDI
- Description
- The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002035 FDA UDI
- 510(k) Number
- K052932 FDA UDI
- FDA Product Code
- MHJ FDA UDI
- GMDN Term
- Cryptosporidium species 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: Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA)
Cryptosporidium Ii by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryptosporidium species antigen IVD, kit, enzyme immunoassay (EIA).
- Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC. · Class II
- CRYPTOSPORIDIUM II — TECHLAB, INC. · Class II
Cleared under the same submission
K052932 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Techlab, Inc.
Sources (1)
- FDA UDI bb65abcf-eb20-42ad-b401-18fd08c23431 34 fields · synced May 29, 2026