nCounter Digital Analyzer 5s

Primary DI
00859812006003
Brand
nCounter Digital Analyzer 5s
Company
NANOSTRING TECHNOLOGIES, INC.
Model
NCT-DIGITAL-ANALYZER-FLEX
Catalog number
NCT-DIGITAL-ANALYZER-FLEX
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.
Published
2017-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130010000PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies2013-09-06NYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859812006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859812006003008598120060038598120060030859812006003

GMDN Terms#

Term, Definition table
TermDefinition
Microarray analyser IVD, automatedA mains electricity (AC-powered) 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. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-358-6266info@nanostring.com

Regulatory Flags#

DUNS number
143888712
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859812006010Prosigna Breast Cancer Prognostic Gene Signature AssayPROSIGNA-001PROSIGNA-0012016-09-20
00859812006027Prosigna Breast Cancer Prognostic Gene Signature AssayPROSIGNA-002PROSIGNA-0022016-09-20
00859812006034Prosigna Breast Cancer Prognostic Gene Signature AssayPROSIGNA-003PROSIGNA-0032016-09-20
00859812006041Prosigna Breast Cancer Prognostic Gene Signature AssayPROSIGNA-004PROSIGNA-0042016-09-20
00859812006058Prosigna Breast Cancer Prognostic Gene Signature AssayPROSIGNA-010PROSIGNA-0102016-09-20
00859812006065nCounter Prep Station 5sNCT-PREP-STATION-FLEXNCT-PREP-STATION-FLEX2017-08-16

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