Product code OBZ

Device name

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Medical specialty

Immunology

Device class

2

Regulation number

866.5130

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.

Source

FDA openFDA device classification dataset