Catalog Number

440928

Brand Name

BD ProbeTec™ Urine Preservative Transport

Version/Model Number

440928

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2022

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

K052224,K052224

Product Code

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

0a252bc4-25f7-4997-b16b-864e21aafd8a

Public Version Date

September 15, 2022

Public Version Number

6

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-