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Candida albicans IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Candida albicans IgG ELISA FDA UDI
Generic Name
Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum. FDA UDI
Model / Reference
EIA-3458 FDA UDI
Description
The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum. FDA UDI

Identifiers

Catalog Number
EIA-3458 FDA UDI
Primary DI / UDI-DI
04048474034585 FDA UDI
FDA Product Code
LSG FDA UDI
GMDN Term
Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3165 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Candida albicans immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Candida albicans IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Candida albicans 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
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 03636280-25ae-43b5-940c-4b8eb52770f0 36 fields · synced May 30, 2026