PZH — Serpina1 Variant Detection System Class II
FDA product code PZH covers "Serpina1 Variant Detection System", a Class II medical device regulated under 21 CFR 866.5130. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZH
- Device Class
- Class II
- Regulation Number
- 866.5130
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.