Identity
- Trade Name
- Total Estrogens ELISA FDA UDI
- Generic Name
- Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Total Estrogens ELISA is for the direct quantitative determination of total estrogens (estrone, estradiol, and estriol) in human serum by enzyme immunoassay. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 11-ESTTHU-E01 FDA UDI
- Description
- The Total Estrogens ELISA is for the direct quantitative determination of total estrogens (estrone, estradiol, and estriol) in human serum by enzyme immunoassay. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 11-ESTTHU-E01 FDA UDI
- Primary DI / UDI-DI
- B24211ESTTHUE010 FDA UDI
- FDA Product Code
- JMD FDA UDI
- GMDN Term
- Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1275 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Total Estrogens ELISA by American Laboratory Products Company — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI a2fcfac1-8050-4501-ab40-2e579bc63f01 37 fields · synced May 30, 2026