Identity
- Trade Name
- Free Estriol ELISA FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy. FDA UDI
- Model / Reference
- 20-FE3HU-E01 FDA UDI
- Description
- The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy. FDA UDI
Identifiers
- Catalog Number
- 20-FE3HU-E01 FDA UDI
- Primary DI / UDI-DI
- B24220FE3HUE010 FDA UDI
- FDA Product Code
- CGI FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1265 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)
Free Estriol ELISA by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Salimetrics — SALIMETRICS LLC. · Class III
- Ansh Labs Unconjugated Estriol EIA — Ansh Labs, LLC
- uE3 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
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 a83d0ac9-7948-4b83-9674-1ab9d884d46f 36 fields · synced May 30, 2026