OPY · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5510
Classification
FDA Product Code
OPY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5510
Review panel
IM
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.