Identity
- Trade Name
- IMMULITE® 2000 Systems CEA FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- CEA - IMMULITE - RGT - 200 Tests FDA UDI
- Model / Reference
- 10380994 FDA UDI
- Description
- CEA - IMMULITE - RGT - 200 Tests FDA UDI
Identifiers
- Catalog Number
- L2KCE2 FDA UDI
- Primary DI / UDI-DI
- 00630414961118 FDA UDI
- 510(k) Number
- K980855 FDA UDI
- FDA Product Code
- DHX FDA UDI
- GMDN Term
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 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, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems CEA by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
- Elecsys CEA — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® CEA — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- Elecsys CEA Assay — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Ireland Diagnostics · Class II
Cleared under the same submission
K980855 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI f8c841dc-a8ee-4250-90c4-c019773f031f 37 fields · synced Jun 1, 2026