Alpha-1-Antitrypsin Kit, Qualitative Phenotype

FDA product code OBZ · Class II (moderate risk) · 21 CFR 866.5130 · Immunology

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.

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K213396SPIFE A1AT kitOBZ · Traditional Helena Laboratories, Corp.10/13/2022SE
K063498Hydragel 18 A1AT Isofocusing Kit (PN 4356)OBZ · Traditional Sebia06/11/2007SE