Identity
- Trade Name
- IMMULITE® 1000 Systems E2 CONTROL Estradiol FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, control FDA UDI
- Device Name
- Estradiol - IMMULITE - CTL - 1x2.0mL FDA UDI
- Model / Reference
- 10389765 FDA UDI
- Description
- Estradiol - IMMULITE - CTL - 1x2.0mL FDA UDI
Identifiers
- Catalog Number
- E2TC1 FDA UDI
- Primary DI / UDI-DI
- 00630414974095 FDA UDI
- 510(k) Number
- K932926 FDA UDI
- FDA Product Code
- CHP FDA UDI
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, control 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
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
IMMULITE® 1000 Systems E2 CONTROL Estradiol by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Estradiol (oestradiol) (E2) IVD, control.
- Atellica IM eE2 MCM — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- ADVIA Centaur® eE2 MCM — Siemens Healthcare Diagnostics · Class I
- Alinity — ABBOTT IRELAND · Class I
- VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
- LIAISON® Estradiol II Gen Control Set — Diasorin Inc.
- IMMULITE® Systems E2 Calibration Verification Material Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K932926 also covers:
- IMMULITE® 2000 Systems E2 Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems E2 Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems E2 Estradiol Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Products Ltd
Sources (1)
- FDA UDI b14d4428-d47d-4246-b3fd-7d7521e70969 37 fields · synced May 30, 2026