# Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PIV)
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