Catalog Number

-

Brand Name

Rite Aid Pharmacy

Version/Model Number

Family Planning Pregnancy Test

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 19, 2019

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

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

1fa75fa9-79b4-47ec-b6a6-3186f3e2cc56

Public Version Date

July 31, 2020

Public Version Number

5

DI Record Publish Date

March 06, 2017

Package DI Number

10855606007000

Quantity per Package

24

Contains DI Package

00855606007003

Package Discontinue Date

March 19, 2019

Package Status

Not in Commercial Distribution

Package Type

Case Pack