Catalog Number

-

Brand Name

Cervista HTA System

Version/Model Number

Cervista HTA System Computer

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P080014

Product Code

MAQ

Product Code Name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Public Device Record Key

88977837-f9fa-454b-9219-fa0a2e4e5411

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-