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Bordetella Pertussis IgG

FDA UDI

Class I (US FDA UDI)

by Savyon Diagnostics Ltd

Identity

Trade Name
Bordetella Pertussis IgG FDA UDI
Generic Name
Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis. FDA UDI
Model / Reference
A2231-01M FDA UDI
Description
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis. FDA UDI

Identifiers

Catalog Number
A2231-01M FDA UDI
Primary DI / UDI-DI
07290016332636 FDA UDI
FDA Product Code
GOZ FDA UDI
GMDN Term
Bordetella pertussis immunoglobulin A (IgA) 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Bordetella Pertussis IgG by Savyon Diagnostics Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Savyon Diagnostics Ltd

Sources (1)

  • FDA UDI deaab7d8-2be0-4f6b-a034-246a764dd9d7 35 fields · synced May 30, 2026