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Epstein Barr Virus VCA IgM ELISA

FDA UDI

Class I (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Epstein Barr Virus VCA IgM ELISA FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum. FDA UDI
Model / Reference
EIA-2794 FDA UDI
Description
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum. FDA UDI

Identifiers

Catalog Number
EIA-2794 FDA UDI
Primary DI / UDI-DI
04048474027945 FDA UDI
510(k) Number
K944449 FDA UDI
FDA Product Code
LSE FDA UDI
GMDN Term
Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) 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

Yes

FDA UDI

Epstein Barr Virus VCA IgM ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 253cedc7-1165-45e6-a694-c2ab7cf7eb5c 38 fields · synced May 30, 2026