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Microscan Microstrep Plus Panel Chloramphenicol (1 to 32 Mcg/Ml)

by Dade Behring, Inc. 510(k)

Active United States

510(k) K062293

Overview

The Microscan Microstrep Plus Panel Chloramphenicol is an instrument for auto reader and interpretation of overnight susceptibility systems, used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci. It is designed to test the susceptibility of bacteria to the antimicrobial agent Chloramphenicol at concentrations of 1 to 32 mcg/ml.

The panel is supplied for use in microbiology settings and is incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator. The device has been cleared by the FDA, with a product code of LRG and regulation number 866.1640. It is used to determine bacterial antimicrobial agent susceptibility, including for Streptococcus pneumoniae.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062293 Date24 Aug 2006ClearedStatusActive

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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LRG
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Microscan Microstrep Plus Panel Chloramphenicol used for?

    The Microscan Microstrep Plus Panel Chloramphenicol is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

  • How is the panel supplied and incubated?

    The panel is supplied for use in microbiology settings and is incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator.

  • What concentrations of Chloramphenicol can the panel test?

    The panel can test the susceptibility of bacteria to Chloramphenicol at concentrations of 1 to 32 mcg/ml.

  • What is the regulatory status of the device?

    The device has been cleared by the FDA with a product code of LRG and regulation number 866.1640.