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 Sebia and 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
Cleared
Oct 13, 2022
SPIFE A1AT kit
Helena Laboratories, Corp.
Immunology
360d
Cleared
Jun 11, 2007
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
Sebia
Immunology
203d
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.