Catalog Number

-

Brand Name

H.E.B

Version/Model Number

One Step Ovulation Predictor

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

K002867,K002867,K002867

Product Code

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

acda6ef2-112e-4859-8526-f6b9848b7cd4

Public Version Date

October 22, 2021

Public Version Number

2

DI Record Publish Date

February 06, 2019

Package DI Number

10041220524423

Quantity per Package

24

Contains DI Package

00041220524426

Package Discontinue Date

October 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipping case