nCounter Digital Analyzer 5s

Basic Information

• Brand Name: nCounter Digital Analyzer 5s
• Primary DI: 00859812006003
• Version / Model: NCT-DIGITAL-ANALYZER-FLEX
• Catalog Number: NCT-DIGITAL-ANALYZER-FLEX
• Company Name: NANOSTRING TECHNOLOGIES, INC.
• Labeler DUNS: 143888712
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-16
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: d4cf2240-cd27-4d2b-9565-fec7c3fef1b9

Device Description

The Digital analyzer 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 Digital Analyzer is a multi-channel epifluorescence scanner configured specifically for use with NanoString’s nCounter Test Kit Cartridges.The nCounter Digital Analyzer collects data by taking images of the immobilized fluorescent reporters in the sample cartridge with a CCD camera through a microscope objective lens. 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57851	Microarray analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes and/or digital imaging techniques.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859812006003	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]