Catalog Number

IA01-001

Brand Name

Q-STAIN® X Autostainer

Version/Model Number

IA01-001

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

-

Product Code

KPA

Product Code Name

Slide Stainer, Automated

Public Device Record Key

bbf62c1e-31b9-49b3-b65f-19eb4a6d63ee

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-