Catalog Number

95-449

Brand Name

HPV-HR

Version/Model Number

GENFIND DNA EXTRACTION KIT

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

Yes

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

e6460478-dfc0-44b1-a766-4e2ef1ba58ec

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-