Identity
- Trade Name
- VIDAS® CMV IgG FDA UDI
- Generic Name
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma. FDA UDI
- Model / Reference
- 30204-01 FDA UDI
- Description
- VIDAS ® CMV IgG (CMVG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of CMV IgG concentration in human serum or plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026156831 FDA UDI
- 510(k) Number
- K920661 FDA UDI
- FDA Product Code
- LFZ FDA UDI
- GMDN Term
- Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) 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
Yes
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, enzyme immunoassay (EIA)
VIDAS® CMV IgG by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- Pointe Scientific, Inc. CMV IgG — POINTE SCIENTIFIC, INC. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- CMV IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- CMV IgG ELISA — DRG International, Inc. · Class II
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI e7d4c7aa-acc2-4c1c-9800-424384a991d3 35 fields · synced May 30, 2026