Catalog Number

KC682

Brand Name

Dimension Vista® / Dimension® EXL™ LCTNI CON M

Version/Model Number

10707957

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 06, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K121084,K121084

Product Code

JJX

Product Code Name

SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Public Device Record Key

471f7895-8432-4597-9429-a9d068a6d51e

Public Version Date

July 07, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-