Catalog Number

PMC-3010

Brand Name

Premom Ovulation Cassette Kit (30 LH + 10 HCG)

Version/Model Number

PM2-C, PM1-C

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

CEP

Product Code Name

Radioimmunoassay, Luteinizing Hormone

Public Device Record Key

c37f6da9-4937-4b2a-96b4-9c23cdf1b6fc

Public Version Date

February 21, 2019

Public Version Number

2

DI Record Publish Date

July 01, 2018

Package DI Number

10855944007199

Quantity per Package

54

Contains DI Package

00855944007192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton