Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Immunoglobulin A Kappa Heavy & Light Chain Combined

FDA product code OPX · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5510
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-06-16 – 2016-06-16

Intended for the in-vitro quantification of iga kappa 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.

↑