Home / 510(k) Clearances / K100818

510(k) K100818

ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 by Meridian Bioscience, Inc. — Product Code OMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
March 23, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C. Difficile Nucleic Acid Amplification Test Assay
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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 OMN

  • DEN120013 — PORTRAIT ANALYZER (April 30, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • K110203 — XPERT C. DIFFICLE/EPI ASSAY (April 7, 2011)
  • K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (February 24, 2011)