Catalog Number

444089

Brand Name

BD FOX™ PCR Extraction Tubes

Version/Model Number

444089

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P160037,P160037

Product Code

MAQ

Product Code Name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Public Device Record Key

51ca1fda-60c4-4480-bca3-52f0c20849e7

Public Version Date

February 27, 2020

Public Version Number

1

DI Record Publish Date

February 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-