OptiView Amplification Kit - Ventana Medical Systems, Inc.

Duns Number:184042521

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More Product Details

Catalog Number

06396518001

Brand Name

OptiView Amplification Kit

Version/Model Number

06396518001

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

NJT

Product Code Name

IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Device Record Status

Public Device Record Key

91d1b135-a675-490d-9eb6-2917b99d7a8e

Public Version Date

June 18, 2021

Public Version Number

2

DI Record Publish Date

February 03, 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