Identity
- Trade Name
- Elecsys CMV IgG FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 09118551190 FDA UDI
Identifiers
- Catalog Number
- 09118551190 FDA UDI
- Primary DI / UDI-DI
- 07613336198469 FDA UDI
- 510(k) Number
- K220911 FDA UDI
- FDA Product Code
- LFZ FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Elecsys CMV IgG by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott Ireland Diagnostics · Class II
- Alinity — Abbott Ireland Diagnostics · Class II
- ADVIA Centaur CMV IgG — Siemens Healthcare Diagnostics · Class II
- Atellica IM CMV IgG — Siemens Healthcare Diagnostics · Class II
- LIAISON® CMV IgG — Diasorin Inc.
- IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 Systems CVG CMV IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys CMV IgG Assay — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K220911 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI ae01cd94-d126-49f4-bdc3-4a8561ee532a 34 fields · synced May 30, 2026