Product code DNW

Device name

Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3300

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