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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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17 records meeting your search criteria returned- Product Code: QHO Product Problem: Incorrect, Inadequate or Imprecise Resultor Readings Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBU COBAS MPX TEST, CE-IVD 10/08/2020
ROCHE MOLECULAR SYSTEMS COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD 09/01/2020
GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY 06/15/2020
GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO ELITE ASSAY 05/19/2020
ROCHE MOLECULAR SYSTEMS, INC. COBAS MPX TEST, CE-IVD 01/28/2020
GRIFOLS DIAGNOSTICS SOLUTIONS INC. PROCLEIX ULTRIO PLUS ASSAY 01/08/2020
GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX ULTRIO PLUS ASSAY 09/28/2018
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