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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
 

 
 
8 records meeting your search criteria returned- Product Code: PEN Patient Problem: Insufficient Information Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 01/13/2022
LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 12/22/2021
LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 12/22/2021
LUMINEX CORPORATION VERIGENE BC-GN NUCLEIC ACID TEST KIT (20 12/22/2021
BIOFIRE DIAGNOSTICS, LLC. FILMARRAY® BLOOD CULTURE IDENTIFICATION 12/14/2021
GENMARK DIAGNOSTICS EPLEX 07/09/2021
GENMARK DIAGNOSTICS, INC EPLEX GRAM NEGATIVE BCID PANEL 06/30/2021
LUMINEX CORPORATION NORTHBROOK, IL VERIGENE I BC-GN ASSAY 12/02/2020
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