FDA.reportPublic FDA data

B.R.A.H.M.S PCT sensitive KRYPTOR

Primary DI
04260157638259
Brand
B.R.A.H.M.S PCT sensitive KRYPTOR
Company
B.R.A.H.M.S GmbH
Model
825.050
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
DEN150009000
K171338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150009000B.R.A.H.M.S PCT sensitive KRYPTORBrahms GmbH2016-02-20PMT
K171338000B R A H M S PCT sensitive KRYPTORBrahms GmbH2017-05-31PRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157638259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157638259042601576382594260157638259

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343844205
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260157630543B.R.A.H.M.S PCT LIA354.1002016-08-17
04260157630406B.R.A.H.M.S PlGF plus KRYPTOR LIN085993N2025-02-26
04260157630413B.R.A.H.M.S sFlt-1 KRYPTOR LIN084593N2025-02-26
04260157632127B.R.A.H.M.S CgA II KRYPTOR839050N839050N2023-09-22
04260157632288B.R.A.H.M.S CgA II KRYPTOR CAL083991N2023-06-20
04260157632295B.R.A.H.M.S CgA II KRYPTOR QC083992N2023-06-20
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 899812016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 899822016-08-17
04260157633230B.R.A.H.M.S KRYPTOR compact SOLUTION 3 899832016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4899842016-08-17
04260157632158B.R.A.H.M.S sFlt-1 KRYPTOR845075N2023-05-22
04260157632196B.R.A.H.M.S PlGF plus KRYPTOR859075N2023-05-22
04260157632455B.R.A.H.M.S PlGF plus KRYPTOR CAL085991N2023-05-19
04260157632462B.R.A.H.M.S PlGF plus KRYPTOR QC085992N2023-05-19
04260157632479B.R.A.H.M.S sFlt-1 KRYPTOR CAL084591N2023-05-19
04260157632486B.R.A.H.M.S sFlt-1 KRYPTOR QC084592N2023-05-19
04260157632875B.R.A.H.M.S PCT sensitive KRYPTOR CAL825912017-08-15
04260157632882B.R.A.H.M.S PCT sensitive KRYPTOR QC 825922016-08-17
04260157638976B.R.A.H.M.S KRYPTOR compact REACT899862016-08-17
04260157638983B.R.A.H.M.S KRYPTOR compact DILCUP899852016-08-17

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
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PMT2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PRI2018-04-02
04987270234167Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.NTM2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PRI2018-04-02
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