Identity
- Trade Name
- Total IgE ELISA FDA UDI
- Generic Name
- Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients. FDA UDI
- Model / Reference
- 25-IGEHU-E01 FDA UDI
- Description
- The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients. FDA UDI
Identifiers
- Catalog Number
- 25-IGEHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225IGEHUE010 FDA UDI
- 510(k) Number
- K992528 FDA UDI
- FDA Product Code
- DGC FDA UDI
- GMDN Term
- Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- Not 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
Total IgE ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 4936a725-0199-48d6-b660-30ca372f0bff 38 fields · synced May 30, 2026