FDA.reportPublic FDA data

TruCal Procalcitonin Calibrator Set

Primary DI
04051839013682
Brand
TruCal Procalcitonin Calibrator Set
Company
DiaSys Diagnostic Systems GmbH
Model
173109943082
Catalog number
173109943082
Device description
The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

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
04051839013682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051839013682040518390136824051839013682

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be 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
04051839013668DiaSys Procalcitonin FS1731899430181731899430182025-08-01
04051839013675TruLab Procalcitonin Bi-Level Controls5998099430865998099430862025-08-01
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

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