Catalog Number

14051254355

Brand Name

HistoCore SPECTRA Workstation Kit

Version/Model Number

000000014051254355

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)

Yes

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

bebee68a-1231-46b5-bfb3-8e3dbaa50f4b

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

December 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-