Product code NRF

Device name

Material, Quality Control, Semen Analysis

Medical specialty

Hematology

Device class

2

Regulation number

864.8625

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.

Source

FDA openFDA device classification dataset