FDA.reportPublic FDA data

Anti-Bordetella pertussis toxin ELISA (IgA)

Primary DI
04049016085492
Brand
Anti-Bordetella pertussis toxin ELISA (IgA)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EI 2050-9601 A
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04049016085492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016085492040490160854924049016085492

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis immunoglobulin A (IgA) 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 A (IgA) 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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
00382902258513BD Difco™ Bordetella Pertussis AntigenBECTON, DICKINSON AND COMPANYGOX2018-05-25
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
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