OPY — Igal Heavy & Light Chain Combined Class II
FDA product code OPY covers "Igal Heavy & Light Chain Combined", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel.
Classification Details
- Product Code
- OPY
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
Intended for the in-vitro quantification of iga lambda concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.