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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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9 records meeting your search criteria returned- Product Code: OOI Patient Problem: Insufficient Information Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
MERIDIAN BIOSCIENCE, INC. ALETHIA MERIDIAN BIOSCIENCE 11/20/2023
MERIDIAN BIOSCIENCE, INC. ALETHIA MERIDIAN BIOSCIENCE 11/20/2023
MERIDIAN BIOSCIENCE, INC. ALETHIA MERIDIAN BIOSCIENCE 11/20/2023
MERIDIAN BIOSCIENCE INC. REVOGENE 01/28/2022
BECTON, DICKINSON & CO. (SPARKS) BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT 01/18/2022
MERIDIAN BIOSCIENCE INC. REVOGENE 10/14/2021
ABBOTT DIAGNOSTICS SCARBOROUGH INC. ID NOW INSTRUMENT 12/12/2020
ABBOTT DIAGNOSTICS SCARBOROUGH INC. ID NOW INSTRUMENT 12/12/2020
LUMINEX CORPORATION LUMINEX ARIES-M12V1-IVD / LABORATORY PCR 10/01/2020
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