OBZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Alpha-1-Antitrypsin Kit, Qualitative Phenotype
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SPIFE A1AT kit (K213396) | Helena Laboratories, Corp. | 2022-10-13 |
| HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) (K063498) | Sebia | 2007-06-11 |
Track OBZ automatically
Every clearance here is in the API, with alerts when new ones post.