Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3010](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3010) → GSX — Antisera, Acinetobacter Calcoaceticus, All Varieties

# GSX · Antisera, Acinetobacter Calcoaceticus, All Varieties

_Microbiology · 21 CFR 866.3010 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSX

## Overview

- **Product Code:** GSX
- **Device Name:** Antisera, Acinetobacter Calcoaceticus, All Varieties
- **Regulation:** [21 CFR 866.3010](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3010)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Acinetobacter calcoaceticus serological reagents are devices that consist of Acinetobacter calcoaceticus antigens and antisera used to identify this bacterium from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by the bacterium Acinetobacter calcoaceticus and provides epidemiological information on disease caused by this microorganism. This organism becomes pathogenic in patients with burns or with immunologic deficiency, and infection can result in sepsis (blood poisoning).

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSX](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GSX)

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