Catalog Number

VS-MA-00892-00

Brand Name

SQA-Vision Sperm Quality Analyzer

Version/Model Number

VS-MA-00892-00

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012352

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

3ba2142d-dd48-4f37-9286-f4cb3298978a

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-