VENTANA Antibody Diluent with Casein - Ventana Medical Systems, Inc.

Duns Number:184042521

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


More Product Details

Catalog Number

06440002001

Brand Name

VENTANA Antibody Diluent with Casein

Version/Model Number

06440002001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

JCC

Product Code Name

pH buffer

Device Record Status

Public Device Record Key

7875d0d7-d5b7-4db2-aa1f-3928af30d85a

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VENTANA MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 134
2 A medical device with a moderate to high risk that requires special controls. 11
3 A medical device with high risk that requires premarket approval 7