Identity
- Trade Name
- ASCA-CHEK FDA UDI
- Generic Name
- Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE. FDA UDI
- Model / Reference
- T5016 FDA UDI
- Description
- The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002325 FDA UDI
- FDA Product Code
- NBT FDA UDI
- GMDN Term
- Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5785 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: Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)
Asca-Chek by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 58823104-4221-4226-b978-04b1c67d0417 33 fields · synced May 30, 2026