FDA.reportPublic FDA data

LIAISON® Treponema Assay

Primary DI
08056771100618
Brand
LIAISON® Treponema Assay
Company
DIASORIN SPA
Model
310480
Published
2016-09-24
Public version status
Update
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
K061247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061247000DIASORIN LIAISON TREPONEMA ASSAYDiaSorin, Inc.2006-07-31LIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771100618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771100618080567711006188056771100618

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-439-9710info@diasorin.com

Regulatory Flags#

DUNS number
630822989
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771100625LIAISON® VZV IgG3104952016-09-24
08056771100632LIAISON® Control VZV IgG3104962016-09-24
08056771103015LIAISON BRAHMS PCT II GEN3180902018-04-05
08056771104265LIAISON® XL MUREX Anti-HDV3182602026-01-12
08056771104272LIAISON® XL MUREX Control Anti-HDV3182612026-01-12
08056771100199LIAISON® anti-HAV3102002016-09-24
08056771100205LIAISON® Control anti-HAV3102012016-09-24
08056771100571LIAISON® Rubella IgG3104602016-09-24
08056771100588LIAISON® Rubella IgG TRI-Controls3104612016-09-24
08056771102148LIAISON® XLI00502016-09-24
08056771101943LIAISON® CMV IgM3107502016-09-24
08056771102872LIAISON MDXMOL10012017-04-04
08056771102889LIAISON MDXMOL10112017-04-04
08056771103268LIAISON Quantiferon TB Gold Plus3110202019-12-09
08056771104029LIAISON® Biotrin Parvovirus B19 IgG Plus3115502024-04-08
08056771104036LIAISON® Biotrin Control Parvovirus B19 IgG Plus3115512024-04-08
08056771104166LIAISON® VZV IgG HT 3118702024-03-15
08056771104173LIAISON® Control VZV IgG HT 3118712024-03-15
08056771104098LIAISON QUANTIferon TB Gold Plus3110402023-12-14
08056771104081LIAISON QUANTIferon TB Gold Plus3110402023-09-08

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
05391516746908Trinity 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
00630414580173ADVIA Centaur® SYPHSiemens Healthcare Diagnostics Inc.LIP2016-09-24