Product code MYR

Device name

Test, Donor, Syphilis, Antigens, Treponemal

Medical specialty

Microbiology

Device class

2

Regulation number

866.3830

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset