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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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92 records meeting your search criteria returned- Product Code: MTF Product Problem: Low Test Results Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BECKMAN COULTER ACCESS HYBRITECH PSA REAGENT 12/08/2015
BECKMAN COULTER ACCESS HYBRITECH PSA 11/16/2015
BECKMAN COULTER ACCESS HYBRITECH PROSTATE-SPECIFIC ANTIG 11/16/2015
ROCHE DIAGNOSTICS TOTAL (FREE + COMPLEXED) PSA - PROSTATE- 10/15/2015
ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA 07/30/2015
ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA 07/27/2015
ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA 04/27/2015
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PSA ASSAY 03/16/2015
ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA 03/06/2015
ROCHE DIAGNOSTICS "TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA 10/10/2014
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