Product code DNS

Device name

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep.

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3320

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset