PZH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Serpina1 Variant Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.
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| Record | Firm | Date |
|---|---|---|
| A1AT Genotyping Test (K211115) | Progenika Biopharma S.A., A Grifols Company | 2021-05-13 |
| A1AT Genotyping Test (K192858) | Progenika Biopharma S.A., A Grifols Company | 2019-11-05 |
| A1AT Genotyping Test (K171868) | Progenika Biopharma S.A., A Grifols Company | 2017-11-11 |
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