Catalog Number

YO-FA-01633-00

Brand Name

YO Home Sperm Test

Version/Model Number

YO: Universal 2.0 packed kit - 2 tests

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

-

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

K161493

Product Code

POV

Product Code Name

Semen Analysis Device

Public Device Record Key

b9e61fa0-f158-4339-9fbd-003b12c8a9ca

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-