Catalog Number

-

Brand Name

Equaline

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

K042280,K042280,K042280

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

887e01cd-8688-464b-88e2-67858db4953f

Public Version Date

April 27, 2021

Public Version Number

1

DI Record Publish Date

April 19, 2021

Package DI Number

10041163502977

Quantity per Package

24

Contains DI Package

00041163502970

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case