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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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9 records meeting your search criteria returned- Product Code: MTG Product Problem: Low Test Results Report Date From: 01/1/2009

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ManufacturerBrand NameDate Report Received
ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE PSA REAGENT KIT 04/25/2024
ROCHE DIAGNOSTICS ELECSYS FREE PSA 02/24/2023
ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY 02/15/2022
SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PROSTATE-SPECIFIC ANTI 01/20/2022
ABBOTT IRELAND ARCHITECT FREE PSA REAGENT KIT 06/14/2021
ROCHE DIAGNOSTICS ASKU 11/09/2020
ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE PSA 06/22/2020
ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY 03/06/2019
ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY 08/09/2017
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