Catalog Number

PMS2-S-20

Brand Name

Premom Semi-quantitative Ovulation Test (20 LH strips)

Version/Model Number

PMS2-S

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

-

Product Code

NGE

Product Code Name

Test, Luteinizing Hormone (Lh), Over The Counter

Public Device Record Key

77cf8565-3257-40d5-bf44-905efc9f25a6

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

Package DI Number

10850003180028

Quantity per Package

100

Contains DI Package

00850003180021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton