FDA.reportPublic FDA data

DiaSys Procalcitonin FS

Primary DI
04051839013668
Brand
DiaSys Procalcitonin FS
Company
DiaSys Diagnostic Systems GmbH
Model
173189943018
Catalog number
173189943018
Device description
Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma
Published
2025-08-01
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
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
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
K242294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242294000DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsDiasys Diagnostic Systems GmbH2025-05-09PTF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051839013668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051839013668040518390136684051839013668

GMDN Terms#

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

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328419718
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04051839013675TruLab Procalcitonin Bi-Level Controls5998099430865998099430862025-08-01
04051839013682TruCal Procalcitonin Calibrator Set1731099430821731099430822025-08-01
04051839002891β-Hydroxybutyrate 21 FS1371199430181371199430182018-11-15
04051839002907β-Hydroxybutyrate 21 FS1371199430191371199430192018-11-15
04051839002921β-Hydroxybutyrate 21 Bi-Level Controls5954099430845954099430842018-11-15
04051839002938β-Hydroxybutyrate 21 Linearity Standards1372099430521372099430522018-11-15
04051839002914β-Hydroxybutyrate 21 Tri-Level Controls5957099430855957099430852018-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590736002Access PCTBeckman Coulter, Inc.PTF2023-05-05
15099590719531Access PCTIMMUNOTECHPTF2020-01-31
00380740153953AlinityAbbott Ireland DiagnosticsPTF2019-01-04
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PTF2018-10-05
00380740138905ARCHITECTAbbott GmbHPTF2017-08-16
00380740138912ARCHITECTAbbott GmbHPTF2017-08-16
00380740139032ARCHITECTAbbott GmbHPTF2017-08-16
00380740139049ARCHITECTAbbott GmbHPTF2017-08-16
00657498001950Procalcitonin LiquiColorSTANBIO LABORATORY, L.P.PTF2017-06-26
00657498001967Procalcitonin (PCT) CalibratorsSTANBIO LABORATORY, L.P.PTF2017-06-26
00657498001974Procalcitonin (PCT) Bi-Level ControlsSTANBIO LABORATORY, L.P.PTF2017-06-26