Verigene® Reader (Refurbished) - The Verigene® Reader is the central control of - NANOSPHERE, INC.

Duns Number:164757242

Device Description: The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Verigene® Reader (Refurbished)

Version/Model Number

10-0000-02R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2019

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

615a91e6-7c54-4cbf-9fb4-87a8097141d4

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

November 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NANOSPHERE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 27