FDA.reportPublic FDA data

DM EXL LOCI BRAHMS PCT

Primary DI
00630414238692
Brand
DM EXL LOCI BRAHMS PCT
Company
Siemens Healthcare Diagnostics Inc.
Model
11354447
Catalog number
RF648
Device description
Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Published
2022-11-15
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220262000Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc.2022-08-26PRI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414238692PrimaryGS10
00630414298214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414238692006304142386926304142386920630414238692
00630414298214006304142982146304142982140630414298214

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of procalcitonin (PCT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27
00630414597508Atellica CH hsCRP Calibrator11099412110994122017-12-22
00630414597515Atellica CH CRP_2 Calibrator11099430110994302017-12-22
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414611297Atellica CH RCRP Cal11537245115372452024-02-02
00842768037726Dimension EXL LOCI Troponin I High Sensitive10471068104710682019-10-16
00630414596099Atellica CH Thc11097503110975032017-12-27
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414653259Atellica CH Crea311537567115375672026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236499Elecsys BRAHMS PCTRoche Diagnostics GmbHPRI2026-02-19
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.PRI2018-10-05
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2018-10-05
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 GmbHPRI2017-08-16
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPRI2017-08-16
00380740139032ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPRI2017-08-16
00380740139049ARCHITECTAbbott GmbHPRI2017-08-16
00380740139049ARCHITECTAbbott GmbHPMT2017-08-16
04260157632875B.R.A.H.M.S PCT sensitive KRYPTOR CALB.R.A.H.M.S GmbHPMT2017-08-15
04015630940073Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2017-04-21
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SAPMT2016-09-23
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SAPRI2016-09-23
04015630939114Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2016-09-20
04260157630949B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S GmbHPMT2016-08-17