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Cobas Bact

by Roche Diagnostics GmbH Germany PMA

PMA P840065

Product code LON

Overview

The Cobas Bact is an automated antimicrobial susceptibility testing system designed for microbiology laboratories. It performs short-incubation antimicrobial susceptibility tests to identify bacterial resistance patterns, aiding in targeted antibiotic therapy and infection control.

This device is intended for use in clinical microbiology settings and is supplied as a reusable system with FDA Premarket Approval (PMA). It operates under regulatory classification II and is governed by FDA regulation 866.1645, with PMA number P840065. No specific sterility or MRI safety information is provided in the data.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP840065 Date30 May 1986DecidedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

PMA · synced 6 Oct 2026

Generic Name
SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
PMA Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
APRL

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Questions

  • What is the primary purpose of the COBAS BACT system in a clinical setting?

    The COBAS BACT is designed to perform automated antimicrobial susceptibility testing with short-incubation methods. This helps microbiology labs quickly identify bacterial resistance patterns, enabling faster and more targeted antibiotic therapy decisions while supporting infection control efforts.

  • Is the COBAS BACT system reusable or single-use, and what does this mean for maintenance?

    The COBAS BACT is supplied as a reusable system, meaning it is built for repeated use in clinical microbiology labs. This requires proper cleaning, calibration, and maintenance protocols to ensure accurate antimicrobial susceptibility testing over time, as outlined in the manufacturer’s instructions.

  • How is the COBAS BACT regulated by the FDA, and what does this mean for purchasing or implementation?

    The COBAS BACT holds FDA Premarket Approval (PMA) under PMA number P840065, classified as a Class II device under regulation 21 CFR 866.1645. This means it has undergone rigorous review by the FDA’s Microbiology Devices Panel (MI) and must comply with ongoing compliance requirements, including periodic reporting and adherence to labeling specifications.

  • Are there specific storage requirements or considerations for the COBAS BACT system?

    The provided data does not specify storage conditions (e.g., temperature, humidity) or shelf-life requirements for the COBAS BACT system itself. However, as a reusable medical device, it should be stored in a clean, dry environment when not in use, following the manufacturer’s guidelines to prevent contamination or damage to components.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P840065 24 fields · synced 6 Oct 2026