Catalog Number

-

Brand Name

CVP Health

Version/Model Number

One Step Pregnancy Test

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

K012215,K012215,K012215

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

b4ffef6c-e11a-430e-8624-148810489897

Public Version Date

December 14, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2020

Package DI Number

10761706168490

Quantity per Package

6

Contains DI Package

20761706168497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping case