FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747646
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
40-2017
Catalog number
40-2017
Device description
Alkaline Phosphatase Developing Solution, 45mL
Published
2016-09-19
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
JWLAntigen, Treponema Pallidum For Fta-Abs Test
LLLExtractable Antinuclear Antibody, Antigen And Control
LSRReagent, Borrelia Serological Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWLAntigen, Treponema Pallidum For Fta-Abs TestMicrobiology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
LSRReagent, Borrelia Serological ReagentMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747646053915167476465391516747646

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.

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
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
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
00845533002950Anti-Borrelia VlsE1/pepC10 IgG/IgMZEUS SCIENTIFIC, INC.LSR2026-02-18
00850049545259AccuDiag ™Diagnostic Automation, Inc.LSR2024-03-06
00850054026378QMedix™Diagnostic Automation, Inc.LSR2024-01-31
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
04048474028096B. burgdorferi IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028102Borrelia burgdorferi IgG (Lyme) ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
04048474028119Borrelia burgdorferi IgM (Lyme) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLSR2023-08-29
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239028099B. burgdorferi IgG/IgM ELISADRG International IncLSR2023-08-24
00840239028105Borrelia burgdorferi IgG (Lyme) ELISADRG International IncLSR2023-08-24
00840239028112Borrelia burgdorferi IgM (Lyme) ELISA DRG International IncLSR2023-08-24
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239027733ANA Screen IgG ELISA DRG International IncLLL2023-08-23
B3507202500Gold Standard Diagnostics Is-anti-SS-A ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
EVIRBTCFDK1Borrelia All-In-One ViraChip Deca KitViramed Biotech AGLSR2022-11-08
EVIRBTCFOK1Borrelia All-In-One ViraChip Test KitViramed Biotech AGLSR2022-11-08
B350GSD0110310Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-10-28
B350GSD0110250Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
B350GSD0110260Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitGold Standard Diagnostics CorporationLSR2022-09-24
00845533001854ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test SystemZEUS SCIENTIFIC, INC.LSR2022-04-27
00894175000022AccuDiag ™ Diagnostic Automation, Inc.LSR2021-08-10
B350GSD0110270Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test KitGold Standard Diagnostics CorporationLSR2021-07-20
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGold Standard Diagnostics CorporationLLL2020-07-27