Dengue Serological Reagents

OSU · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3945

Classification

FDA Product Code: OSU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3945
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 6

Source

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