OPYClass II
Igal Heavy & Light Chain Combined
Immunology · 21 CFR 866.5510
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.
MDR events2All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances0All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.