Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard 10026958

GUDID 06438153007289

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.

Thermo Fisher Scientific Oy

Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS)
Primary Device ID06438153007289
NIH Device Record Key166933b0-3bab-412a-896a-e07cd513a863
Commercial Distribution StatusIn Commercial Distribution
Brand NameCascadion™ SM 25-Hydroxy Vitamin D Internal Standard
Version Model NumberNONE
Catalog Number10026958
Company DUNS540096708
Company NameThermo Fisher Scientific Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438153007289 [Primary]

FDA Product Code

PSL25-Oh-Vitamin D Mass Spectrometry Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

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06438153000266 - L-Turn, TCA2023-08-03 L-Turn, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the hand
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Trademark Results [Cascadion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CASCADION
CASCADION
88862979 not registered Live/Pending
Thermo Fisher Scientific Oy
2020-04-07
CASCADION
CASCADION
88862976 not registered Live/Pending
Thermo Fisher Scientific Oy
2020-04-07
CASCADION
CASCADION
85712872 4487048 Live/Registered
Thermo Fisher Scientific Oy
2012-08-24

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