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Bordetella pertussis IgG ELISA

FDA UDI

Class I (US FDA UDI)

by DRG International, Inc.

Identity

Trade Name
Bordetella pertussis IgG ELISA FDA UDI
Generic Name
Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma) FDA UDI
Model / Reference
EIA-3450 FDA UDI
Description
The DRG Bordetella pertussis IgG Enzyme Immunoassay Kit provides materials for the qualitative and semi-quantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum and plasma (EDTA-, heparin- or citrate plasma) FDA UDI

Identifiers

Catalog Number
EIA-3450 FDA UDI
Primary DI / UDI-DI
00840239034502 FDA UDI
FDA Product Code
GOX FDA UDI
GMDN Term
Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3065 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: Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella pertussis IgG ELISA by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bordetella pertussis immunoglobulin A (IgA)/IgG/IgM 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 9fc4a7c2-2962-4d85-8f78-af5e37b58433 36 fields · synced Jun 8, 2026