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EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
- Model / Reference
- NA-5112 FDA UDI
Identifiers
- Catalog Number
- NA-5112 FDA UDI
- Primary DI / UDI-DI
- B110NA51120 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, reagent 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
Yes
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
EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 80596720-07ac-41e3-ab62-327e26f14e11 37 fields · synced Jun 8, 2026