Identity
- Trade Name
- Human Chorionic Gonadotropin ELISA FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. FDA UDI
- Model / Reference
- 25-HCGHU-E01 FDA UDI
- Description
- The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. FDA UDI
Identifiers
- Catalog Number
- 25-HCGHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24225HCGHUE010 FDA UDI
- 510(k) Number
- K991741 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
Human Chorionic Gonadotropin ELISA by American Laboratory Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K991741 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
- American Laboratory Products Company
Sources (1)
- FDA UDI ac58050b-5187-41d3-a2f8-dccf4283fbfc 38 fields · synced May 30, 2026