Identity
- Trade Name
- Ultrasensitive Estradiol ELISA FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative measurement of Estradiol in serum and plasma. For In Vitro Diagnostic Use. FDA UDI
- Model / Reference
- 20-ESTHUU-E01 FDA UDI
- Description
- The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative measurement of Estradiol in serum and plasma. For In Vitro Diagnostic Use. FDA UDI
Identifiers
- Catalog Number
- 20-ESTHUU-E01 FDA UDI
- Primary DI / UDI-DI
- B24220ESTHUUE010 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1260 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
Ultrasensitive Estradiol 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Laboratory Products Company
Sources (1)
- FDA UDI 0c534d01-751d-4c7e-9ec1-0245e40781b9 37 fields · synced Jun 8, 2026