Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

SBZ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3986

Classification

FDA Product Code: SBZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3986
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Test for detection of antibodies associated with syphilis performed by lay users is an in vitro diagnostic device used for detection of antibodies in clinical specimens for use in home settings, or similar environments. The device is intended to aid in diagnosis of syphilis and intended for prescription use or over-the-counter use.

Market data

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

Source

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