Thermo Fisher Scientific Oy

Address:2 RATASTIE,VANTAA Uusimaa,FI

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

25-Oh-Vitamin D Mass Spectrometry Test System (PSL) (5) Hexokinase, Glucose (CFR) (1)

Premarket Exempt

No Yes

Clear

Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set - 06438153007241 Catalog Number : 10026927

Device Description : The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 2 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.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : Yes

Product Code : PSL

Prescription Use : Yes

Device Count : 1

Cascadion™ SM 25-Hydroxy Vitamin D Control 1 - 06438153007258 Catalog Number : 10026928

Device Description : The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 2 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 Controls are for quality control of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : Yes

Product Code : PSL

Prescription Use : Yes

Device Count : 1

Cascadion™ SM 25-Hydroxy Vitamin D Control 2 - 06438153007265 Catalog Number : 10026929

Device Description : The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 2 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 Controls are for quality control of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : Yes

Product Code : PSL

Prescription Use : Yes

Device Count : 1

Cascadion™ SM 25-Hydroxy Vitamin D Control 3 - 06438153007272 Catalog Number : 10026930

Device Description : The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 2 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 Controls are for quality control of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : Yes

Product Code : PSL

Prescription Use : Yes

Device Count : 1

Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard - 06438153007289 Catalog Number : 10026958

Device Description : The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 2 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. This in vitro diagnostic device is intended for clinical laboratory use only.The Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard is used to ensure the accuracy of the assay on the Cascadion™ SM Clinical Analyzer by correcting for systematic and random errors due to variations in sample preparation, chromatography, and detection. The Internal Standard is also used as a precipitating agent in the sample preparation method.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : Yes

Product Code : PSL

Prescription Use : Yes

Device Count : 1

Glucose (HK) - 16438153817793 Catalog Number : 981779

Device Description : For in vitro diagnostic use in the quantitative determination of the glucose con For in vitro diagnostic use in the quantitative determination of the glucose concentration in human serum, plasma or urine on Konelab and Indiko analyzers.

Device Class : 2

Duns Number: 540096708

Premarket Exempt : No

Product Code : CFR

Prescription Use : No

Device Count : 1

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