FDA.reportPublic FDA data

BD Difco™ Bordetella Pertussis Antigen

Primary DI
00382902258513
Brand
BD Difco™ Bordetella Pertussis Antigen
Company
BECTON, DICKINSON AND COMPANY
Model
225851
Catalog number
225851
Device description
BD Difco™ Bordetella Pertussis Antigen
Published
2018-05-25
Public version status
Update
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
00382902258513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902258513003829022585133829022585130382902258513

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Bordetella species antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple species of Bordetella bacteria, which may include B. pertussis, B. parapertussis and/or B. bronchiseptica in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474061338Bordetella pertussis Toxin (PT) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOX2023-09-01
04048474034509Bordetella pertussis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOX2023-08-29
00840239061331Bordetella pertussis Toxin (PT) IgG ELISADRG International IncGOX2023-08-26
00840239034502Bordetella pertussis IgG ELISADRG International IncGOX2023-08-24
EVIRBPSADK1Bordetella pertussis ViraStripe IgA Deca KitViramed Biotech AGGOX2023-07-17
EVIRBPSAOK1Bordetella pertussis ViraStripe IgA Test KitViramed Biotech AGGOX2023-07-17
EVIRBPSGDK1Bordetella pertussis ViraStripe IgG Deca KitViramed Biotech AGGOX2023-07-17
EVIRBPSGOK1Bordetella pertussis ViraStripe IgG Test KitViramed Biotech AGGOX2023-07-17
00404847461336Bordetella pertussis Toxin (PT) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOX2021-06-11
00404847434507Bordetella pertussis IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGOX2021-06-07
B24220BPGHUE010Bordetella pertussis IgG ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.GOX2020-06-18
04049016085430EUROLINE Bordetella pertussis (IgA)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016085447EUROLINE Bordetella pertussis (IgG)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016085461EUROLINE Bordetella pertussis (IgA)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016085478EUROLINE Bordetella pertussis (IgG)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016085492Anti-Bordetella pertussis toxin ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016085508Anti-Bordetella pertussis toxin ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
04049016096047Anti-Bordetella pertussis ELISA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGOX2016-09-24
05391516746311Trinity BiotechMARDX DIAGNOSTICS, INC.GOX2016-09-18
05391516747868Trinity BiotechMARDX DIAGNOSTICS, INC.GOX2016-09-18
05391516747875Trinity BiotechMARDX DIAGNOSTICS, INC.GOX2016-09-18
05391516747882Trinity BiotechMARDX DIAGNOSTICS, INC.GOX2016-09-18
05391516747899Trinity BiotechMARDX DIAGNOSTICS, INC.GOX2016-09-18