FDA.reportPublic FDA data

Lumipulse G TP-N Immunoreaction Cartridges Set

Primary DI
04987270235041
Brand
Lumipulse G TP-N Immunoreaction Cartridges Set
Company
FUJIREBIO INC.
Model
235041
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K153145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153145000Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.2016-07-05LIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987270235041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987270235041049872702350414987270235041

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius10 Degrees Celsius
Special Storage Condition, Specify00right side up with care; no vibration
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-240-3800customersupport@fdi.com

Regulatory Flags#

DUNS number
710873907
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
04987270235058Lumipulse G BRAHMS PCT Immunoreaction Cartridges2350582018-04-02
04987270235584Lumipulse Infectious Diseases Controls2355842025-07-31
04987270230466Lumipulse G Dilution Cartridges2304662019-12-27
04987270234440Soda Lime for LUMIPULSE System2344402020-01-10
04987270235447Lumipulse G B-Amyloid 1-42-N Plasma2354472025-01-06
04987270235454Lumipulse G B-Amyloid 1-42-N Plasma Calibrator2354542025-01-06
04987270235485Lumipulse G B-Amyloid Controls (Plasma)-N2354852025-01-06
04987270226964Beckman Coulter PK TP System226964PH30002016-09-16
04987270234938Lumipulse G BRAHMS PCT Calibrator Set2349382018-04-02
04987270234945Lumipulse BRAHMS PCT Controls2349452018-04-02
04987270234884Lumipulse G B-Amyloid 1-42 Calibrator Set2348842022-10-31
04987270234891Lumipulse G B-Amyloid 1-40 Calibrator Set2348912022-10-31
04987270234907Lumipulse B-Amyloid Controls2349072022-10-31
04987270231432Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges2314322022-11-10
04987270231753Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges2317532022-11-10
04987270231869Lumipulse G SARS-CoV-2 Ag Calibrator Set2318692023-02-01
04987270231876Lumipulse SARS-CoV-2 Ag Controls2318762023-02-01
04987270260340Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges2603402023-02-01
04987270234259LUMIPULSE G12002342592019-12-27
04987270230190Lumipulse G whole PTH Immunoreaction Cartridges2301902019-12-18

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