OBZ

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Product code

OBZ

Device name

Alpha-1-Antitrypsin Kit, Qualitative Phenotype

Device class

Class 2

21 CFR

21 CFR 866.5130

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).