Product code DEI— Immunology
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
- Classification name
- Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DEI
FDA has cleared devices under product code DEI between 1977 and 1984, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1984
- 1977
Top applicants under product code DEI
Recent clearances under product code DEI
Data sourced from openFDA. This site is unofficial and independent of the FDA.