Catalog Number

K6455

Brand Name

Dimension Vista® Flex® reagent cartridge CA125

Version/Model Number

10464357

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

K100321,K100321

Product Code

LTK

Product Code Name

TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Public Device Record Key

6863a5c1-cd49-48e3-8f17-4de4b08f0147

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-