Identity
- Trade Name
- EBNA Positive Control FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Model / Reference
- NA-5140 FDA UDI
Identifiers
- Catalog Number
- NA-5140 FDA UDI
- Primary DI / UDI-DI
- B110NA51400 FDA UDI
- 510(k) Number
- K894626 FDA UDI
- FDA Product Code
- LLM FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3235 FDA UDI
- Commercial Distribution
- Not 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
No
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
EBNA Positive Control by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 5b9a8ca3-16e1-40d4-9985-7c70264c10f4 37 fields · synced Jun 8, 2026