Identity
- Trade Name
- Free Estriol ELISA FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The DRG 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
- EIA-1612 FDA UDI
- Description
- The DRG 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
- EIA-1612 FDA UDI
- Primary DI / UDI-DI
- 00840239016126 FDA UDI
- FDA Product Code
- CGI FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay 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
Yes
FDA UDI
Category: Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
Free Estriol ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Free Estriol — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
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- Free Estriol — DRG International, 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
- DRG International, Inc.
Sources (1)
- FDA UDI b1f25285-5a97-48ed-9f36-2977629c0904 36 fields · synced May 30, 2026