Identity
- Trade Name
- Estrone ELISA FDA UDI
- Generic Name
- Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- For the direct quantitative determination of Estrone by enzyme immunoassay in human serum. FDA UDI
- Model / Reference
- EIA-4079 FDA UDI
- Description
- For the direct quantitative determination of Estrone by enzyme immunoassay in human serum. FDA UDI
Identifiers
- Catalog Number
- EIA-4079 FDA UDI
- Primary DI / UDI-DI
- 00840239040794 FDA UDI
- FDA Product Code
- CGF FDA UDI
- GMDN Term
- Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1280 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: Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA)
Estrone ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Estrone (oestrone) IVD, kit, enzyme immunoassay (EIA).
- Estrone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Estrone ELISA — IBL America · Class I
- DBC Estrone ELISA — Diagnostics Biochem Canada Inc · Class I
- Estrone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Estrone ELISA — Diasource Immunoassays, S.A. · Class I
- Estrone ELISA — American Laboratory Products Company · Class I
- Estrone ELISA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- Estrone ELISA — 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 f2fb9b0c-cfba-42cd-a4fe-7855b8666431 36 fields · synced Jun 8, 2026