Catalog Number

SWAB/G-50

Brand Name

Xpert Swab Specimen Collection Kit

Version/Model Number

SWAB/G-50

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

-

Product Code

QBD

Product Code Name

Microbial Nucleic Acid Storage And Stabilization Device

Public Device Record Key

6395970c-3610-4084-81d3-8f99739a5717

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

October 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-