Product code DGX— Immunology
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
- Classification name
- Ng1m(A), Antigen, Antiserum, Control
- Device class
- Class 1
- Regulation
- 21 CFR 866.5065
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DGX
FDA has cleared device under product code DGX, all in 1984, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code DGX
Recent clearances under product code DGX
Data sourced from openFDA. This site is unofficial and independent of the FDA.