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Anti-West Nile Virus ELISA (IgG)

FDA UDI

Class II (US FDA UDI)

by EUROIMMUN Medizinische Labordiagnostika AG

Identity

Trade Name
Anti-West Nile Virus ELISA (IgG) FDA UDI
Generic Name
West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
EI 2662-9601 G FDA UDI

Identifiers

Primary DI / UDI-DI
04049016028178 FDA UDI
510(k) Number
K153303 FDA UDI
FDA Product Code
NOP FDA UDI
GMDN Term
West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3940 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

No

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: West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-West Nile Virus ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
EUROIMMUN Medizinische Labordiagnostika AG

Sources (1)

  • FDA UDI 17791b1a-82d6-4b61-9e90-ab84c635e129 34 fields · synced Jun 8, 2026