

# QIM · Bartonella Spp. Serological Reagents

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/MI-misc/QIM

## Overview

- **Product Code:** QIM
- **Device Name:** Bartonella Spp. Serological Reagents
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## Identification

Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/MI/MI-misc/QIM](https://fda.innolitics.com/submissions/MI/MI-misc/QIM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
