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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

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