nCounter Prep Station 5s - The Prep Station is a part of the nCounter DX - NANOSTRING TECHNOLOGIES, INC.

Duns Number:143888712

Device Description: The Prep Station is a part of the nCounter DX Analysis System, which consists of two instr The Prep Station is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station 5s and the nCounter Digital Analyzer 5s. The Prep Station is the automated fluidic handling component of the nCounter DX Analysis System which processes samples post-hybridization. The samples prepared by the Prep Station are used for data collection on the nCounter Digital Analyzer. Together,the NanoString nCounter DX Analysis System (liquid handling robot and epifluorescence scanner) delivers direct, multiplexed measurements of gene expression through digital readouts of the relative abundance of mRNA transcripts using the following steps: 1) a hybridization of the mRNA to fluorescent Reporter Probes and Capture Probes, 2) purification of the target/probe complexes using nCounter Prep Plates containing reagents necessary for post-hybridization processing and immobilization onto the nCounter Cartridge on the nCounter Prep Station, and 3) analysis of the nCounter Cartridge on the nCounter Digital Analyzer to provide a test result.

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More Product Details

Catalog Number

NCT-PREP-STATION-FLEX

Brand Name

nCounter Prep Station 5s

Version/Model Number

NCT-PREP-STATION-FLEX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NSU

Product Code Name

Instrumentation For Clinical Multiplex Test Systems

Device Record Status

Public Device Record Key

151140ba-6d99-45ad-9b59-80bcab41c88b

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

August 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOSTRING TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7