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MERIFLUOR EBV VCA IgM IFA

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
MERIFLUOR EBV VCA IgM IFA FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein-Barr virus (EBV) in human serum. It is of value in providing supportive information for the diagnosis of active infection with EBV. FDA UDI
Model / Reference
EB150 FDA UDI
Description
The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein-Barr virus (EBV) in human serum. It is of value in providing supportive information for the diagnosis of active infection with EBV. FDA UDI

Identifiers

Catalog Number
EB150 FDA UDI
Primary DI / UDI-DI
00840733101946 FDA UDI
510(k) Number
K822734 FDA UDI
FDA Product Code
JRY 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
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

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

MERIFLUOR EBV VCA IgM IFA by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI 110e733a-0d1c-4c9d-8f14-bc6e697528b1 38 fields · synced Jun 8, 2026