Catalog Number

-

Brand Name

H.E.B

Version/Model Number

One Step Ovulation Predictor

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

-

Product Code

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

32b7961a-8b9f-402c-9478-23abbb2a522f

Public Version Date

December 15, 2020

Public Version Number

2

DI Record Publish Date

February 06, 2019

Package DI Number

00141220103161

Quantity per Package

24

Contains DI Package

00041220103164

Package Discontinue Date

December 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Shipping Case