FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516747943
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
90-1610
Catalog number
90-1610
Device description
FITC Mounting Medium (pH 7.5), 3.0 mL
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
LEBMounting Media
LOOReagent, Leishmanii Serological
LSRReagent, Borrelia Serological Reagent
MIVImmunofluorescent Assay, T. Cruzi
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System
NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEBMounting MediaPathology1
LOOReagent, Leishmanii SerologicalMicrobiology1
LSRReagent, Borrelia Serological ReagentMicrobiology2
MIVImmunofluorescent Assay, T. CruziMicrobiology1
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Immunology2
NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemUnknownN
NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516747943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516747943053915167479435391516747943

GMDN Terms#

Term, Definition table
TermDefinition
Borrelia burgdorferi 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 Borrelia burgdorferi in a clinical specimen, using an immunoblot 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
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
05391516746250Trinity Biotech40-5065M/B40-5065M/B2016-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533002950Anti-Borrelia VlsE1/pepC10 IgG/IgMZEUS SCIENTIFIC, INC.LSR2026-02-18
00845533002028Glomerular Basement Membrane (Primate Kidney)ZEUS SCIENTIFIC, INC.MVJ2025-10-17
04049016151982Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
04049016152002Mounting medium (IIFT)EUROIMMUN Medizinische Labordiagnostika AGLEB2025-07-03
00613647028612FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00613647028650FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028616FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
20613647028654FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEB2025-04-30
00860012688937ClaraMount™ Coverslip mounting mediumClarapath, Inc.LEB2024-08-23
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