Catalog Number

05235880190

Brand Name

cobas® 4800 HPV Amplification/Detection Kit

Version/Model Number

05235880190

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

-

Product Code

MAQ

Product Code Name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Public Device Record Key

f44c7dde-8813-4300-8236-84aa6fa6c2f9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 10, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-