Catalog Number

-

Brand Name

H.E.B

Version/Model Number

Early Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 2020

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

54866586-4e91-41f6-b533-1de77b5b3057

Public Version Date

December 15, 2020

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

00141220910042

Quantity per Package

24

Contains DI Package

00041220910045

Package Discontinue Date

December 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Case