Identity
- Trade Name
- Atellica IM eE2 MCM FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, control FDA UDI
- Device Name
- Enhanced Estradiol (eE2) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
- Model / Reference
- 10995564 FDA UDI
- Description
- Enhanced Estradiol (eE2) Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL FDA UDI
Identifiers
- Catalog Number
- 10995564 FDA UDI
- Primary DI / UDI-DI
- 00630414598888 FDA UDI
- 510(k) Number
- K102904 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Estradiol (oestradiol) (E2) IVD, control
Atellica IM eE2 MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Estradiol (oestradiol) (E2) IVD, control.
- IMMULITE® Systems E2 Calibration Verification Material Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- Alinity — ABBOTT IRELAND · Class I
- IMMULITE® 1000 Systems E2 CONTROL Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
- LIAISON® Estradiol II Gen Control Set — Diasorin Inc.
- ADVIA Centaur® eE2 MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K102904 also covers:
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI a9daa7a5-617e-4f2d-b7e1-ead348d40e45 37 fields · synced Jun 8, 2026