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Merifluor Ebv-Na

FDA UDI

Class I (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
MERIFLUOR EBV-NA FDA UDI
Generic Name
Epstein-Barr virus (EBV) antigen IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests. FDA UDI
Model / Reference
EN100 FDA UDI
Description
The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests. FDA UDI

Identifiers

Catalog Number
EN100 FDA UDI
Primary DI / UDI-DI
00840733101953 FDA UDI
510(k) Number
K880043 FDA UDI
FDA Product Code
LLM FDA UDI
GMDN Term
Epstein-Barr virus (EBV) antigen 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-Na 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 bffbb3de-4d96-43fb-b0f0-90218e2c1375 38 fields · synced Jun 6, 2026