Alpha-1-Antitrypsin Kit, Qualitative Phenotype
The Alpha-1-Antitrypsin Qualitative Phenotype Kit (product code OBZ) is an immunology in vitro diagnostic device used as an aid in the diagnosis of alpha-1-antitrypsin (AAT) deficiency by determining the phenotypic variant of AAT in patient samples, used in conjunction with clinical and other laboratory findings. AAT deficiency is a genetic condition that can cause liver disease and emphysema. This device is FDA Class 2 under regulation 866.5130 in the Immunology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
Research product code OBZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OBZ
- Device Class
- FDA class 2
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.