FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746397
Brand
Trinity Biotech
Company
MARDX DIAGNOSTICS, INC.
Model
31-8010
Catalog number
31-8010
Device description
FTA-ABS, 10 Well Slides, 10 each pack
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
JWLAntigen, Treponema Pallidum For Fta-Abs Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWLAntigen, Treponema Pallidum For Fta-Abs TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746397053915167463975391516746397

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum immunoglobulin G (IgG)/IgM 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 G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

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
05391516747646Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-19
05391516748704Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516748711Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516749114Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516749121Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516749138Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516749145Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18
05391516749152Trinity BiotechMARDX DIAGNOSTICS, INC.JWL2016-09-18