Catalog Number

K6452

Brand Name

Dimension Vista® System FPSA Flex® Reagent Cartridge

Version/Model Number

10445091

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P020027,P020027,P020027,P020027,P020027,P020027,P020027,P020027

Product Code

MTG

Product Code Name

Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Public Device Record Key

0510eb5a-af0e-490e-abf6-6f6e9d56d56e

Public Version Date

November 18, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-