FDA.reportPublic FDA data

Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set

Primary DI
06438153007241
Brand
Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set
Company
Thermo Fisher Scientific Oy
Model
NONE
Catalog number
10026927
Device description
The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 25-Hydroxy Vitamin D (25-OH Vit D) in human serum through the quantitative measurement and combination of 25-Hydroxy Vitamin D3 and 25-Hydroxy Vitamin D2 on the Cascadion™ SM Clinical Analyzer. This liquid- chromatography – tandem mass spectrometry (LC-MS/MS) assay is to be used as an aid in the assessment of Vitamin D sufficiency.The Cascadion™ SM 25-Hydroxy Vitamin D Calibrators are for the calibration of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.
Published
2020-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PSL25-Oh-Vitamin D Mass Spectrometry Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSL25-Oh-Vitamin D Mass Spectrometry Test SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438153007241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438153007241064381530072416438153007241

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy Vitamin D IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius-15 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540096708
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438153000129Entry, TCA19520152023-07-26
06438153000143Exit, TCA19520162023-07-26
06438153000211Conveyor 600, TCA19520212023-07-26
06438153000228Conveyor 1200, TCA19520222023-07-26
06438153000235Conveyor 1500, TCA19520232023-07-26
06438153000259Conveyor 2400, TCA19520252023-07-26
06438153000266L-Turn, TCA19520272023-07-26
06438153000297Conveyor 900, TCA19520302023-07-26
06438153000303Conveyor 2100, TCA19520312023-07-26
06438153520139Buffer, TCA19520132023-07-26
06438153000099Interface, TCA ARCHITECT i2000SR19522342023-07-25
06438153000242Conveyor 1800, TCA19520242023-07-25
06438153000327Decapper Flex, TCA19520392023-07-25
06438153000358Perpendicular Bypass, TCA Vitros 5.1 FS AT19520432023-07-25
06438153000419Internal U-Turn, TCA19520462023-07-25
06438153000433Z-Turn, right, TCA19520482023-07-25
06438153000440Z-Turn, left, TCA19520492023-07-25
06438153000471Sysmex HST Interface, TCA19520542023-07-25
06438153000488Stago STA-R Interface, TCA19520552023-07-25
06438153000549Parallel Bypass, TCA Vitros 5.1 FS19521312023-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336232149Ionify Vitamin D 25Roche Diagnostics GmbHPSL2025-06-04
06438153007258Cascadion™ SM 25-Hydroxy Vitamin D Control 1Thermo Fisher Scientific OyPSL2020-03-02
06438153007265Cascadion™ SM 25-Hydroxy Vitamin D Control 2Thermo Fisher Scientific OyPSL2020-03-02
06438153007272Cascadion™ SM 25-Hydroxy Vitamin D Control 3Thermo Fisher Scientific OyPSL2020-03-02
06438153007289Cascadion™ SM 25-Hydroxy Vitamin D Internal StandardThermo Fisher Scientific OyPSL2020-03-02
00842365100120Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100144Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100151Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100168Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100127Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100141Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100158Vitamin D 200 SeriesAB SciexPSL2017-11-06
10842365100165Vitamin D 200 SeriesAB SciexPSL2017-11-06
00842365100212Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100021Vitamin D 200M Assay for the TopazTM SystemAB SciexPSL2017-07-07
00842365100090Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100106Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100113Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100137Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100175Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100182Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100199Vitamin D 200 SeriesAB SciexPSL2017-07-07
00842365100205Vitamin D 200 SeriesAB SciexPSL2017-07-07
10842365100219Vitamin D 200 SeriesAB SciexPSL2017-07-07