HPV 3 in 1 System Control Slides - Ventana Medical Systems, Inc.

Duns Number:184042521

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More Product Details

Catalog Number

05273587001

Brand Name

HPV 3 in 1 System Control Slides

Version/Model Number

05273587001

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

KIR

Product Code Name

CELLS, ANIMAL AND HUMAN, CULTURED

Device Record Status

Public Device Record Key

f1f7ab6b-ade3-4ded-a394-b977edbc6cb0

Public Version Date

June 18, 2021

Public Version Number

2

DI Record Publish Date

January 29, 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