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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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11 records meeting your search criteria returned- Product Code: KPA Product Problem: False Negative Result Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BIOMERIEUX SA PREVI COLOR GRAM INSTRUMENT V2 - 414292 05/24/2022
VENTANA MEDICAL SYSTEMS, INC. VENTANA ULTRA STAINER 11/03/2021
VENTANA MEDICAL SYSTEMS, INC. VENTANA ULTRA STAINER 11/03/2021
VENTANA MEDICAL SYSTEMS, INC. ROCHE VENTANA ULTRA STAINER 11/03/2021
DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48 11/13/2020
DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48 08/05/2020
DAKO NORTH AMERICA, INC AUSTOSTAINER LINK 48 07/17/2020
VENTANA MEDICAL SYSTEMS, INC. / ROCHE DI VENTANA ULTRA 03/27/2019
DAKO DENMARK A/S DAKO OMNIS 04/20/2016
DAKO DENMARK A/S DAKO OMNIS 04/15/2016
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