Identity
- Trade Name
- Bio-Rad Laboratories FDA UDI
- Generic Name
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Mumps IgG EIA FDA UDI
- Model / Reference
- 25182 FDA UDI
- Description
- Mumps IgG EIA FDA UDI
Identifiers
- Catalog Number
- 25182 FDA UDI
- Primary DI / UDI-DI
- 00847865010771 FDA UDI
- 510(k) Number
- K980059 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Bio-Rad Laboratories by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ELISA Mumps IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
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- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
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Cleared under the same submission
K980059 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 2883e092-1302-4ec8-a6f1-c2136c393687 38 fields · synced Jun 8, 2026