Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting alpha-1-antitrypsin, the major serine protease inhibitor in plasma that protects lung tissue from neutrophil elastase, using FITC as a fluorescent conjugate, with antigen, antiserum, and control components for immunofluorescence-based testing. Alpha-1-antitrypsin deficiency is associated with emphysema and liver disease. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEI, regulated under 21 CFR 866.5130, within the Immunology specialty.
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Basic Information
- Product Code
- DEI
- Device Class
- FDA class 2
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.