Home / 510(k) Clearances / K123423

510(k) K123423

ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT by Meridian Bioscience, Inc. — Product Code OZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2013
Date Received
November 6, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mycoplasma Pneumoniae Dna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Other clearances by Meridian Bioscience, Inc.

  • K243922 — Revogene (March 20, 2025)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K210976 — Curian Campy (December 23, 2021)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K163273 — TRU Legionella (February 21, 2017)

Other clearances for product code OZX

  • K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Dire (June 13, 2016)
  • K152800 — illumigene Mycoplasma DNA Amplification Assay (October 23, 2015)