FDA.reportPublic FDA data

Lumipulse BRAHMS PCT Controls

Primary DI
04987270234945
Brand
Lumipulse BRAHMS PCT Controls
Company
FUJIREBIO INC.
Model
234945
Published
2018-04-02
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
NTMAntigen, Inflammatory Response Marker, Sepsis
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
PRIProcalcitonin Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTMAntigen, Inflammatory Response Marker, SepsisMicrobiology2
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensMicrobiology2
PRIProcalcitonin AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172713000Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc.2017-12-10PRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987270234945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987270234945049872702349454987270234945

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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
04987270230206Lumipulse G Whole PTH Calibrators2302062019-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236499Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2026-02-19
00816870023441PCT AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023458PCT AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
00816870023465PCT AccuBind ELISA Test System - 96 WellsMONOBIND, INC.NTM2024-09-13
00816870023472PCT AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NTM2024-09-13
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PRI2022-11-15
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
00630414298214DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
10758750032938VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750032945VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033287VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033294VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
07613336166635Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2020-04-30
07613336166642Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2020-04-30
00380740153953AlinityAbbott Ireland DiagnosticsPMT2019-01-04
00380740153953AlinityAbbott Ireland DiagnosticsPRI2019-01-04
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2018-10-05
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PRI2018-10-05
04987270234938Lumipulse G BRAHMS PCT Calibrator SetFUJIREBIO INC.NTM2018-04-02
04987270234167Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PRI2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.NTM2018-04-02
00630414599694Atellica IM PCTSiemens Healthcare Diagnostics Inc.NTM2018-02-06
00630414599700Atellica IM PCT QCSiemens Healthcare Diagnostics Inc.NTM2018-02-06
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138905ARCHITECTAbbott GmbHPRI2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPRI2017-08-16
00380740139032ARCHITECTAbbott GmbHPRI2017-08-16