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Mrsa/Sa Elite Mgb

by Elitech

510(k) K112937

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK112937 Date1 Jun 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mrsa/Sa Elite Mgb is a nucleic acid amplification test system designed for the detection of Methicillin-resistant Staphylococcus aureus from direct specimens. It functions by identifying specific DNA sequences to assist in the laboratory diagnosis of bacterial infections.

This device is regulated under FDA 510(k) clearance as a class 2 medical device. It is intended for use in microbiology settings for the analysis of clinical samples.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MRSA/SA Elite Mgb used for?

    The MRSA/SA Elite Mgb is a nucleic acid amplification test system designed to detect Methicillin-resistant Staphylococcus aureus DNA directly from clinical specimens, assisting in the laboratory diagnosis of bacterial infections by identifying specific genetic markers associated with MRSA.

  • How is the MRSA/SA Elite Mgb supplied and intended for use?

    The device is supplied as a nucleic acid amplification test system intended for use in microbiology settings to analyze clinical samples, such as nasal swabs or wound specimens, for the presence of MRSA DNA, and is not described as single-use or reusable in the provided data.

  • What regulatory pathway was used for the MRSA/SA Elite Mgb?

    The MRSA/SA Elite Mgb received FDA 510(k) clearance through a traditional submission process, with the decision based on a finding of substantial equivalence to a legally marketed predicate device, as indicated by the decision code SESE and clearance type Traditional.