Product code GNM

Device name

Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

Medical specialty

Microbiology

Device class

1

Regulation number

866.3145

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset