Catalog Number

800-20301

Brand Name

Carrier Box, ETC, Slide, IVD

Version/Model Number

800-20301

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

BK130051

Product Code

NSU

Product Code Name

Instrumentation For Clinical Multiplex Test Systems

Public Device Record Key

d8fde59d-e0e1-4293-b117-ac4aea47d355

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-