Identity
- Trade Name
- EBV Negative Control FDA UDI
- Generic Name
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Model / Reference
- EBN-5010 FDA UDI
Identifiers
- Catalog Number
- EBN-5010 FDA UDI
- Primary DI / UDI-DI
- B110EBN50100 FDA UDI
- 510(k) Number
- K893240 FDA UDI
- FDA Product Code
- LJN FDA UDI
- GMDN Term
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, controlEpstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, controlEpstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
EBV Negative Control by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control.
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 17e57ea6-3f14-4c49-bc0d-9e4913504ba9 36 fields · synced May 30, 2026