Identity
- Trade Name
- VIDAS® Mumps IgG FDA UDI
- Generic Name
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus FDA UDI
- Model / Reference
- 30218 FDA UDI
- Description
- VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026064525 FDA UDI
- 510(k) Number
- K923903 FDA UDI
- FDA Product Code
- LJY FDA UDI
- GMDN Term
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3380 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: Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS® Mumps IgG by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- NovaLisa Mumps Virus IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
- ELISA Mumps IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Anti-Mumps Virus AT ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ELISA Mumps IgG Test System — ZEUS SCIENTIFIC, INC.
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 48cff733-d406-43c4-b8a3-02afd5973f70 35 fields · synced Jun 8, 2026