Catalog Number

SWAB/A-50

Brand Name

Xpert Vaginal/Endocervical Specimen Collection Kit

Version/Model Number

SWAB/A-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

K173840

Product Code

LIO

Product Code Name

Device, Specimen Collection

Public Device Record Key

1b17e25a-ea50-4bce-9f62-8d2d61cb7e42

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

July 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-