Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart C — Microbiology Devices](/submissions/MI/subpart-c%E2%80%94microbiology-devices) → [21 CFR 866.2050](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2050) → OUS — Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt

# OUS · Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt

_Microbiology · 21 CFR 866.2050 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OUS

## Overview

- **Product Code:** OUS
- **Device Name:** Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt
- **Regulation:** [21 CFR 866.2050](/submissions/MI/subpart-c%E2%80%94microbiology-devices/866.2050)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

A staphylococcal typing bacteriophage is a device consisting of a bacterial virus intended for medical purposes to identify pathogenic staphylococcal bacteria through use of the bacteria's susceptibility to destruction by the virus. Test results are used principally for the collection of epidemiological information.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K120563](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OUS/K120563.md) | KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT | Microphage, Inc. | Mar 30, 2012 | SESE |
| [K102342](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OUS/K102342.md) | KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT | Microphage, Inc. | May 5, 2011 | SESE |

## Top Applicants

- Microphage, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OUS](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/OUS)

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