FDA.reportPublic FDA data

Atellica IM BRAHMS PCT

Primary DI
00630414246550
Brand
Atellica IM BRAHMS PCT
Company
Siemens Healthcare Diagnostics Inc.
Model
11202699
Catalog number
11202699
Device description
Procalcitonin (PCT) Atellica IM - RGT 100T
Published
2018-10-05
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
PMTDevice to detect and measure procalcitonin (PCT) in human clinical specimens
PRIProcalcitonin assay
PTFAssay to measure PCT to aid in the risk assessment of critically ill patients on their first day of ICU admission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensMicrobiology2
PRIProcalcitonin AssayMicrobiology2
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181002000Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.2018-07-16PMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414246550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414246550006304142465506304142465500630414246550

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, kit, chemiluminescent 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 chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, protect from light, do not freeze, resuspend
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
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236499Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2026-02-19
04051839013668DiaSys Procalcitonin FSDiaSys Diagnostic Systems GmbHPTF2025-08-01
15099590736002Access PCTBeckman Coulter, Inc.PTF2023-05-05
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PRI2022-11-15
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
15099590719531Access PCTIMMUNOTECHPTF2020-01-31
00380740153953AlinityAbbott Ireland DiagnosticsPMT2019-01-04
00380740153953AlinityAbbott Ireland DiagnosticsPTF2019-01-04
00380740153953AlinityAbbott Ireland DiagnosticsPRI2019-01-04
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PRI2018-04-02
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PRI2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
00380740138905ARCHITECTAbbott GmbHPTF2017-08-16
00380740138905ARCHITECTAbbott GmbHPRI2017-08-16
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPTF2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPRI2017-08-16
00380740139032ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPRI2017-08-16
00380740139032ARCHITECTAbbott GmbHPTF2017-08-16
00380740139049ARCHITECTAbbott GmbHPTF2017-08-16