FDA.reportPublic FDA data

IMMULITE® Systems SYP CONTROL Syphilis Screen

Primary DI
00630414976686
Brand
IMMULITE® Systems SYP CONTROL Syphilis Screen
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10469593
Catalog number
LSYCM
Device description
Syphillis - IMMULITE - CTL - 2x6mL
Published
2016-09-24
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
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
K091361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091361000IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEMSiemens Healthcare Diagnostics2009-12-16LIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414976686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414976686006304149766866304149766860630414976686

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.

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(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
08056771100618LIAISON® Treponema AssayDIASORIN SPALIP2016-09-24