Catalog Number

-

Brand Name

PB-MAX™ Karyotyping Medium

Version/Model Number

12557021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KIQ

Product Code Name

KIT, CULTURE, CHROMOSOME

Public Device Record Key

b610f9b5-54a3-46c6-b0ca-a4c73be6870a

Public Version Date

August 02, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

30190302002473

Quantity per Package

10

Contains DI Package

10190302002479

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case