Catalog Number

-

Brand Name

ThinPrep Pap Test

Version/Model Number

ThinPrep Microscope Slides

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

P950039,P950039

Product Code

MKQ

Product Code Name

Processor, cervical cytology slide, automated

Public Device Record Key

398dee87-cda2-4a45-991c-1a936743e328

Public Version Date

November 16, 2020

Public Version Number

5

DI Record Publish Date

September 11, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-