Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

OPL · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3510

Classification

FDA Product Code: OPL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3510
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

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