Catalog Number

-

Brand Name

Stix

Version/Model Number

1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041273,K041273

Product Code

LCX

Product Code Name

KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Public Device Record Key

5d4e6701-98b0-414f-a216-19bb2505097f

Public Version Date

May 18, 2021

Public Version Number

3

DI Record Publish Date

August 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-