# Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
> **Product code: PUQ** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3510
## Classification
- **FDA Product Code:** PUQ
- **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:** N
## Definition

The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PUQ)
---
*AI Analytics · CC0 1.0*