Catalog Number

-

Brand Name

Rite Aid Pharmacy

Version/Model Number

Family Planning Ovulation Predictor One Step

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 11, 2021

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

f7f10cea-6c93-429b-ba49-02bfe2091f94

Public Version Date

February 12, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

10011822337370

Quantity per Package

6

Contains DI Package

00011822337373

Package Discontinue Date

February 11, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping Case