Catalog Number

-

Brand Name

Topcare

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

b8679a81-e575-47c0-960c-485880fd310a

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 06, 2019

Package DI Number

10036800163208

Quantity per Package

6

Contains DI Package

00036800163201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case