OBZ — Alpha-1-Antitrypsin Kit, Qualitative Phenotype Class II
FDA product code OBZ covers "Alpha-1-Antitrypsin Kit, Qualitative Phenotype", a Class II medical device regulated under 21 CFR 866.5130. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OBZ
- Device Class
- Class II
- Regulation Number
- 866.5130
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.