Identity
- Trade Name
- Bio-Rad Laboratories FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EB VCA IgM EIA FDA UDI
- Model / Reference
- 25185 FDA UDI
- Description
- EB VCA IgM EIA FDA UDI
Identifiers
- Catalog Number
- 25185 FDA UDI
- Primary DI / UDI-DI
- 00847865010801 FDA UDI
- 510(k) Number
- K033780 FDA UDI
- FDA Product Code
- LJN FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3235 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: Epstein-Barr virus (EBV) immunoglobulin M (IgM) 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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Also classified as Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
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- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ELISA EBV-VCA IgM Q Test System — ZEUS SCIENTIFIC, INC.
Cleared under the same submission
K033780 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 b7882a9b-aa32-4fb3-a3bc-1ebe5faef35b 38 fields · synced May 30, 2026