Identity
- Trade Name
- Total Estrogens ELISA FDA UDI
- Generic Name
- Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Enzyme immunoassay (ELISA) for the quantitative determination of Total Estrogens in human serum. FDA UDI
- Model / Reference
- IB59134 FDA UDI
- Description
- Enzyme immunoassay (ELISA) for the quantitative determination of Total Estrogens in human serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B652IB59134 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
- 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA)
Total Estrogens ELISA by IBL America — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA).
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
- IBL America
Sources (1)
- FDA UDI be20ba54-45b2-4460-ab90-f495a81d0076 35 fields · synced May 30, 2026