Catalog Number

3000000000384

Brand Name

ReadiMag FFPE DNA Kit

Version/Model Number

64 Tests

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

JJH

Product Code Name

Clinical Sample Concentrator

Public Device Record Key

1606d9a6-b90c-4ea8-8b36-71dba10c33e9

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-