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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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12 records meeting your search criteria returned- Product Code: LOL Product Problem: False Negative Result Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM 11/17/2021
ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT 04/16/2021
ABBOTT GMBH ALINITY I HAVAB IGM REAGENT KIT 01/11/2021
ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT 12/05/2020
ABBOTT GMBH ARCHITECT HAVAB-M REAGENT KIT 11/18/2020
ABBOTT IRELAND ARCHITECT HBSAG REAGENT KIT 11/11/2020
ABBOTT GMBH ARCHITECT HAVAB-IGM 09/22/2020
ABBOTT GMBH ARCHITECT HAVAB-IGM 08/28/2020
ABBOTT GERMANY ALINITY I HAVAB IGM REAGENT KIT 07/25/2019
ABBOTT GERMANY ARCHITECT HAVAB-M 03/06/2019
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