Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

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

Classification

FDA Product Code: SGG
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: N

Definition

The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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