510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OPYClass II

Igal Heavy & Light Chain Combined

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

OPY is the FDA product code for Igal Heavy & Light Chain Combined, a class II device type, regulated under 21 CFR 866.5510. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OPY
Device name
Igal Heavy & Light Chain Combined
FDA 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.
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code