FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747899
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
40-6196P
Catalog number
40-6196P
Device description
B. Pertussis PT/FHA EIA Test System, EIA for the detection of antibody to Bordetella pertussis PT and FHA, 96 Tests
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05391516747899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747899053915167478995391516747899

GMDN Terms#

Term, Definition table
TermDefinition
Bordetella pertussis total antibody IVD, kit, immunoblotA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Bordetella pertussis in a clinical specimen, using an immunoblot 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

Contacts#

Phone, Email table
PhoneEmail
800-325-3424info@trinitybiotech.com

Regulatory Flags#

DUNS number
154281349
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516747585Trinity Biotech90-160790-16072016-09-18
05391516747943Trinity Biotech90-161090-16102016-09-19
05391516748698Trinity Biotech20-0464820-046482016-09-18
05391516748919Trinity Biotech20-0400620-040062016-09-18
05391516748926Trinity Biotech20-0400220-040022016-09-18
05391516747851Trinity Biotech40-3025G40-3025G2016-09-18
05391516746182Trinity Biotech32-5100G32-5100G2016-09-18
05391516746199Trinity Biotech32-5100M32-5100M2016-09-18
05391516747721Trinity Biotech40-101340-10132016-09-19
05391516747738Trinity Biotech41-900241-90022016-09-19
05391516748735Trinity Biotech44-2020GV44-2020GV2016-09-18
05391516748742Trinity Biotech44-2020M44-2020M2016-09-19
05391516746151Trinity Biotech30-712030-71202016-09-18
05391516746168Trinity Biotech30-718030-71802016-09-18
05391516746175Trinity Biotech30-736030-73602016-09-18
05391516746205Trinity Biotech40-2075G40-2075G2016-09-18
05391516746212Trinity Biotech40-2075M40-2075M2016-09-18
05391516746229Trinity Biotech40-5065G40-5065G2016-09-18
05391516746236Trinity Biotech40-5065G/B40-5065G/B2016-09-18
05391516746243Trinity Biotech40-5065M40-5065M2016-09-18

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
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