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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 BIOTESTCELL A2 04/30/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B 04/15/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B 04/11/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B 04/11/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPECELL A1 & B 04/11/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH REAGENT RED BLOOD CELLS IH-CELL A1 & B 04/11/2019
MICROTYPING SYSTEMS BLOOD GROUPING REAGENT MTS A/B/D MONOCLO 03/13/2019
MICROTYPING SYSTEMS BLOOD GROUPING REAGENT MTS A/B/D MONOCLO 03/10/2019
IMMUCOR, INC. GALILEO ECHO 01/14/2019
BIO-RAD MEDICAL DIAGNOSTICS GMBH ERYTYPE S ABD+REV A1,B 01/10/2019
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