IMMULITE® 2000 Systems CMM CMV IgM
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE 2000 CMV IgM EUDAMEDIMMULITE® 2000 Systems CMM CMV IgM FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_LLB_DUB-C_C_KIT_CMV IgM EUDAMEDCMV IgM Ab - IMMULITE - RGT - 200 tests FDA UDI
- Model / Reference
- IVDR_67_LLB_DUB-C_C_KIT_CMV IgM EUDAMED10381320 EUDAMED10370302 FDA UDI
- Description
- CMV IgM Ab - IMMULITE - RGT - 200 tests FDA UDI
Identifiers
- Catalog Number
- L2KCM2(D) FDA UDI
- Primary DI / UDI-DI
- 00630414961163 EUDAMED00630414985725 FDA UDI
- Basic UDI-DI
- 0405686901445VL EUDAMED
- 510(k) Number
- K100433 FDA UDI
- FDA Product Code
- LKQ FDA UDI
- EMDN Code
- W0105040204 CMV IGM EUDAMED
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3175 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems CMM CMV IgM by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
K100433 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 5575c51e-7413-44ba-93dc-2879d56c18cf 37 fields · synced Jul 20, 2026
- EUDAMED 9b0d898d-2a2c-4d5f-949e-220be9603817 61 fields · synced Jul 20, 2026