OBZ · Class II · 21 CFR 866.5130

FDA Product Code OBZ: Alpha-1-antitrypsin Kit, Qualitative Phenotype

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.

Leading manufacturers include Helena Laboratories, Corp..

2
Total
2
Cleared
282d
Avg days
2007
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Alpha-1-antitrypsin Kit, Qualitative Phenotype Devices (Product Code OBZ)

2 devices
1–2 of 2
Cleared Oct 13, 2022
SPIFE A1AT kit
K213396
Helena Laboratories, Corp.
Immunology · 360d

About Product Code OBZ - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code OBZ since 2007, with 2 receiving FDA clearance (average review time: 282 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

OBZ devices are reviewed by the Immunology panel. Browse all Immunology devices →