FDA.reportPublic FDA data

β-Hydroxybutyrate 21 Linearity Standards

Primary DI
04051839002938
Brand
β-Hydroxybutyrate 21 Linearity Standards
Company
DiaSys Diagnostic Systems GmbH
Model
137209943052
Catalog number
137209943052
Device description
For use as linearity standards in quantitative procedures for β-Hydroxybutyrate
Published
2018-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051839002938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051839002938040518390029384051839002938

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) 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
Premarket exempt
true
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
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
04051839002914β-Hydroxybutyrate 21 Tri-Level Controls5957099430855957099430852018-10-29

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