FDA.reportPublic FDA data

TruLab Procalcitonin Bi-Level Controls

Primary DI
04051839013675
Brand
TruLab Procalcitonin Bi-Level Controls
Company
DiaSys Diagnostic Systems GmbH
Model
599809943086
Catalog number
599809943086
Device description
TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of procalcitonin (PCT) for 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
04051839013675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051839013675040518390136754051839013675

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, controlA material which is used to verify the performance of 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
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
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00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
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00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
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00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
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