Catalog Number

DF13

Brand Name

Dimension® Flex® reagent cartridge ALB

Version/Model Number

10444975

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

K861700,K861700

Product Code

CJW

Product Code Name

BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Public Device Record Key

2f511ec1-ce74-45c9-a2c2-f2bba8ce030b

Public Version Date

June 10, 2022

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

-