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EBV-VCA IgM Test System, 120 Tests

FDA UDI

Class I (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
EBV-VCA IgM Test System, 120 Tests FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
EBM-120 FDA UDI

Identifiers

Catalog Number
EBM-120 FDA UDI
Primary DI / UDI-DI
B110EBM1200 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, kit, fluorescent immunoassay 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

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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

EBV-VCA IgM Test System, 120 Tests by Bion Enterprises, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay.

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 effcec96-c99c-4c20-ae9a-a6932348f76c 36 fields · synced Jun 8, 2026