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Cornybacterium diphtheriae toxin IgG ELISA

FDA UDI

Class I (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Cornybacterium diphtheriae toxin IgG ELISA FDA UDI
Generic Name
Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative determination of IgG class antibodies against Corynebacterium diphtheriae toxin in human serum or plasma (citrate, heparin). FDA UDI
Model / Reference
EIA-3824 FDA UDI
Description
The Corynebacterium diphtheriae toxin IgG ELISA is intended for the quantitative determination of IgG class antibodies against Corynebacterium diphtheriae toxin in human serum or plasma (citrate, heparin). FDA UDI

Identifiers

Catalog Number
EIA-3824 FDA UDI
Primary DI / UDI-DI
04048474038248 FDA UDI
FDA Product Code
GOS FDA UDI
GMDN Term
Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3140 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

Yes

FDA UDI

Category: Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Cornybacterium diphtheriae toxin IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Corynebacterium diphtheriae 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 5941a019-2ad3-44d9-bd9b-c049a5fab7e7 36 fields · synced May 31, 2026