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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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22 records meeting your search criteria returned- Product Code: NIG Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS ELECSYS CA 19-9 02/13/2024
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 02/04/2024
ROCHE DIAGNOSTICS ELECSYS CA 19-9 01/29/2024
ABBOTT GMBH ALINITY I CA 19-9XR REAGENT KIT 11/22/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT 08/25/2022
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