NGB — Test, Glycosylated Hemoglobin, Over The Counter Class II
FDA product code NGB covers "Test, Glycosylated Hemoglobin, Over The Counter", a Class II medical device regulated under 21 CFR 864.7470. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- NGB
- Device Class
- Class II
- Regulation Number
- 864.7470
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Hematology
- Implant
- No