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IMMULITE® Systems CEA Calibration Verification Material
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems CEA Calibration Verification Material FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, control FDA UDI
- Device Name
- CEA CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373684 FDA UDI
- Description
- CEA CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LCECVM FDA UDI
- Primary DI / UDI-DI
- 00630414971179 FDA UDI
- 510(k) Number
- K143639 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Carcinoembryonic antigen (CEA) 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
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: Carcinoembryonic antigen (CEA) IVD, control
IMMULITE® Systems CEA Calibration Verification Material by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
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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 6bc8609c-c9d9-4566-b2da-363db8b0c5fe 37 fields · synced Jun 1, 2026