Product code KSX

Device name

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Medical specialty

Hematology

Device class

2

Regulation number

864.9160

Review panel

HE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset