Identity
- Trade Name
- Estradiol (serum) ELISA FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- The DRG Estradiol CLIA is a chemiluminescence immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma. FDA UDI
- Model / Reference
- CLA-4664 FDA UDI
- Description
- The DRG Estradiol CLIA is a chemiluminescence immunoassay for the quantitative in vitro diagnostic measurement of Estradiol in serum and plasma. FDA UDI
Identifiers
- Catalog Number
- CLA-4664 FDA UDI
- Primary DI / UDI-DI
- 04048474046649 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1260 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: Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Estradiol (serum) ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay.
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- Alinity — ABBOTT IRELAND · Class I
- Atellica IM eE2 — Siemens Healthcare Diagnostics · 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
Sources (1)
- FDA UDI 09083dd8-9363-462a-8fa6-506aab5f6a90 36 fields · synced Jun 1, 2026