OMN

Product Code: OMN


Products Classified as OMN

3530C. Difficile Nucleic Acid Amplification Test AssayMicroorganism Differentiation And Identification Device.

Total Product Life Cycle (TPLC) Devices

3530C. Difficile Nucleic Acid Amplification Test AssayMicroorganism Differentiation And Identification Device.

FDA Consensus Standards

C. Difficile Nucleic Acid Amplification Test Assay [33208]21 CFR §866.2660 🔎

Pre-market Notifications for OMN

K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTFOCUS DIAGNOSTICS, INC.
K110203XPERT C. DIFFICLE/EPI ASSAYCEPHEID
K110012ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10MERIDIAN BIOSCIENCE, INC.
K100818ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920MERIDIAN BIOSCIENCE, INC.

Global Unique Device Identification Database

07332940000042C. Difficile Nucleic Acid Amplification Test Assay
07332940000028C. Difficile Nucleic Acid Amplification Test Assay
20816101025583C. Difficile Nucleic Acid Amplification Test Assay
00840733102172C. Difficile Nucleic Acid Amplification Test Assay
00840733102134C. Difficile Nucleic Acid Amplification Test Assay
00840733101168C. Difficile Nucleic Acid Amplification Test Assay
00840733101120C. Difficile Nucleic Acid Amplification Test Assay
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