Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

PIV · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.4750

Classification

FDA Product Code: PIV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.4750
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 9

Source

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