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
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.