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Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System

FDA UDI

Class I (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
Model / Reference
EB-5012 FDA UDI

Identifiers

Catalog Number
EB-5012 FDA UDI
Primary DI / UDI-DI
B110EB50120 FDA UDI
510(k) Number
K893240 FDA UDI
FDA Product Code
LJN FDA UDI
GMDN Term
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent 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

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

Category: Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagentEpstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent

Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K893240 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bion Enterprises, Ltd.

Sources (1)

  • FDA UDI 60d56b77-07be-4309-a58d-426977bbdef8 36 fields · synced May 29, 2026