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Candida albicans IgG ELISA

FDA UDI

Class II (US FDA UDI)

by DRG International, Inc.

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
00840239034588 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 30 Milliliter FDA UDI
Total Volume — 14 Milliliter FDA UDI
Total Volume — 20 Milliliter FDA UDI
Total Volume — 2 Milliliter FDA UDI
Total Volume — 100 Milliliter FDA UDI

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

Candida albicans IgG ELISA by DRG International, Inc. — 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 International, Inc.

Sources (1)

  • FDA UDI b2a9192c-9188-4a25-900c-8e1ab71f5b1e 36 fields · synced Jun 8, 2026