| Primary Device ID | 00859812006003 |
| NIH Device Record Key | d4cf2240-cd27-4d2b-9565-fec7c3fef1b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | nCounter Digital Analyzer 5s |
| Version Model Number | NCT-DIGITAL-ANALYZER-FLEX |
| Catalog Number | NCT-DIGITAL-ANALYZER-FLEX |
| Company DUNS | 143888712 |
| Company Name | NANOSTRING TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00859812006010 - Prosigna Breast Cancer Prognostic Gene Signature Assay | 2020-02-06 Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hyb |
| 00859812006027 - Prosigna Breast Cancer Prognostic Gene Signature Assay | 2020-02-06 Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hyb |
| 00859812006034 - Prosigna Breast Cancer Prognostic Gene Signature Assay | 2020-02-06 Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hyb |
| 00859812006041 - Prosigna Breast Cancer Prognostic Gene Signature Assay | 2020-02-06 Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hyb |
| 00859812006058 - Prosigna Breast Cancer Prognostic Gene Signature Assay | 2020-02-06 Used together, the Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Dx Analysis System are a nucleic acid hyb |
| 00859812006003 - nCounter Digital Analyzer 5s | 2019-12-30The 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. |
| 00859812006003 - nCounter Digital Analyzer 5s | 2019-12-30 The Digital analyzer is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station |
| 00859812006065 - nCounter Prep Station 5s | 2019-12-30 The Prep Station is a part of the nCounter DX Analysis System, which consists of two instruments, the nCounter Prep Station 5s a |