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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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6 records meeting your search criteria returned- Product Code: PCH Report Date From: 1/1/2019 Report Date To: 12/31/2019
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ManufacturerBrand NameDate Report Received
BIOFIRE DIAGNOSTICS, INC. BIOFIRE GI PANEL 09/12/2019
BIOFIRE DIAGNOSTICS, LLC BIOFIRE GI PANEL 09/12/2019
BIOFIRE DIAGNOSTICS, LLC BIOFIRE GI PANEL 09/12/2019
BIOFIRE DIAGNOSTICS, LLC BIOFIRE GI PANEL 09/12/2019
BIOFIRE DIAGNOSTICS, LLC FILMARRAY® GASTROINTESTINAL (GI) PANEL 07/11/2019
BIOFIRE DIAGNOSTICS LLC BIOFIRE FILMARRAY GASTROINTESTINAL PANEL 02/26/2019
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