Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol FDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 10702832 FDA UDI
Identifiers
- Catalog Number
- LKE21(D) FDA UDI
- Primary DI / UDI-DI
- 00630414947891 FDA UDI
- 510(k) Number
- K932926 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
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, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems E2 Estradiol by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay.
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Cleared under the same submission
K932926 also covers:
- IMMULITE® 1000 Systems E2 CONTROL Estradiol — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- 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 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 d8d6c924-ba34-4387-b785-f6fe14f3f95e 36 fields · synced May 30, 2026