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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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11 records meeting your search criteria returned- Product Code: DHX Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ABBOTT IRELAND ALINITY I CEA REAGENT KIT 10/27/2022
ABBOTT IRELAND ALINITY I CEA REAGENT KIT 10/27/2022
ROCHE DIAGNOSTICS COBAS E411 03/03/2016
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
BECKMAN COULTER ACCESS CEA 09/22/2015
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