MAK-6® Mouse x Cytokeratin Lyophilized - LIFE TECHNOLOGIES CORPORATION

Duns Number:080131636

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MAK-6® Mouse x Cytokeratin Lyophilized

Version/Model Number

280001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LYE

Product Code Name

CYTOKERATINS

Device Record Status

Public Device Record Key

8f3cd26e-8dbb-4da3-a23c-a3d3ab6504c9

Public Version Date

October 09, 2018

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE TECHNOLOGIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 634
2 A medical device with a moderate to high risk that requires special controls. 77
3 A medical device with high risk that requires premarket approval 12