Catalog Number

K6456

Brand Name

Dimension Vista® Flex® reagent cartridge CA15-3

Version/Model Number

10464344

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100344,K100344

Product Code

MOI

Product Code Name

SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Public Device Record Key

704d17be-2cd0-4a0e-91cf-9e4f23aad6b0

Public Version Date

November 18, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-