Immunoglobulin M Kappa Heavy And Light Chain Combined

PDE · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5510

Classification

FDA Product Code: PDE
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 IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown