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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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415 records meeting your search criteria returned- Product Code: KSZ Product Problem: False Positive Result Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-PANEL 11 03/21/2024
ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION ANALYZER GEL 03/07/2024
IMMUCOR, INC. GALILEO ECHO V2.0 01/31/2024
IMMUCOR, INC. NEO IRIS 01/31/2024
ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION MAX ANALYZER GEL 01/11/2024
ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION ID-MTS ANALYZER 12/13/2023
ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION MAX ANALYZER GEL 11/17/2023
ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION ID-MTS ANALYZER 11/17/2023
IMMUCOR, INC. NEO IRIS 10/18/2023
IMMUCOR, INC. GALILEO ECHO V2.0 10/18/2023
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