FDA.reportPublic FDA data

Bordetella pertussis IgG ELISA

Primary DI
B24220BPGHUE010
Brand
Bordetella pertussis IgG ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
20-BPGHU-E01
Catalog number
20-BPGHU-E01
Device description
The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.
Published
2020-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GOXAntigen, B. Pertussis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GOXAntigen, B. PertussisMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24220BPGHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Bordetella pertussis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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