Catalog Number

5199-1220

Brand Name

hc2 High-Risk HPV DNA Test

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P890064

Product Code

MAQ

Product Code Name

Kit, Dna Detection, Human Papillomavirus

Public Device Record Key

9f9aba8d-cf31-4d77-bc55-b46515410cd6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-