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.

The Cascadion™ SM 25
Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set - NONE

A 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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PSL

Device Name: 25-Oh-Vitamin D Mass Spectrometry Test System

Device Class: 2

Physical State: Mass spectrometer, liquid chromatography-tandem mass spectrometer

Definition: A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Liquid chromatography-tandem mass spectrometry (LC-MS/MS), mass spectrometry

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: In vitro diagnostic use

Regulation Number: 862.1840

Third Party Flag: N

Medical Specialty: CH

Device Id: 06438153007241

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A