FDA.reportPublic FDA data

Trinity Biotech

Primary DI
05391516746908
Brand
Trinity Biotech
Company
CLARK LABORATORIES, INC.
Model
829322
Device description
Wash Buffer Concentrate 20X
Published
2019-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIPEnzyme Linked Immunoabsorption Assay, Treponema PallidumMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014233000CAPTIAM SYPHILIS-G ASSAYTrinity Biotech, Plc2002-01-24LIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391516746908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746908053915167469085391516746908

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVD, manualA buffered wash solution intended to be used in combination with other IVDs during the manual processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

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
1-800-325-3424customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516746595Immco Diagnostics517551752019-10-25
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516743372Trinity Biotech232510023251002016-09-21
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590763626Access Syphilis ReagentBeckman Coulter, Inc.LIP2025-05-07
10758750035052VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
20758750035059VITROSORTHO CLINICAL DIAGNOSTICSLIP2024-09-18
03610522183692BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
03610522207992BioPlexBIO-RAD LABORATORIES, INC.LIP2023-07-28
07613336171950Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
07613336171998Elecsys SyphilisRoche Diagnostics GmbHLIP2022-03-15
00607158000083DPP HIV-SyphilisChembio Diagnostic Systems Inc.LIP2020-12-29
00630414599892Atellica IM Syph QCSiemens Healthcare Diagnostics Inc.LIP2020-09-24
00380740138332AlinityAbbott GmbHLIP2020-05-29
05391516746588Bio-StatCLARK LABORATORIES, INC.LIP2019-12-30
05391516747424Phoenix BiotechCLARK LABORATORIES, INC.LIP2019-12-30
05391516746687Bio-RadCLARK LABORATORIES, INC.LIP2019-12-27
05391516746861Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516746892Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516747226Trinity BiotechCLARK LABORATORIES, INC.LIP2019-12-27
05391516746847Phoenix BiotechCLARK LABORATORIES, INC.LIP2019-08-06
05391516746915Phoenix BiotechCLARK LABORATORIES, INC.LIP2019-08-06
00380740138196AlinityAbbott GmbHLIP2018-07-11
00630414599885Atellica IM SyphSiemens Healthcare Diagnostics Inc.LIP2018-02-06
03610522004980BioPlex 2200BIO-RAD LABORATORIES, INC.LIP2018-02-05
03610522015597BioPlex 2200BIO-RAD LABORATORIES, INC.LIP2018-02-05
03610520138267BioPlex 2200BIO-RAD LABORATORIES, INC.LIP2017-07-25
03610520992692BioPlex 2200BIO-RAD LABORATORIES, INC.LIP2017-07-25
03610520653012BioPlex 2200BIO-RAD LABORATORIES, INC.LIP2017-07-25
00868926000302Syphilis Health CheckVEDALABLIP2017-05-19
04015630940356Elecsys SyphilisRoche Diagnostics GmbHLIP2017-05-10
04015630934881Elecsys SyphilisRoche Diagnostics GmbHLIP2016-10-28
08056771100618LIAISON® Treponema AssayDIASORIN SPALIP2016-09-24
00630414580173ADVIA Centaur® SYPHSiemens Healthcare Diagnostics Inc.LIP2016-09-24