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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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20 records meeting your search criteria returned- Product Code: LIP Product Problem: False Positive Result Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
ABBOTT GMBH ALINITY S SYPHILIS REAGENT KIT 02/15/2022
BIO-RAD LABORATORIES, INC. BIOPLEX 2200 12/27/2021
BIO-RAD LABORATORIES, INC BIOPLEX 2200 SYPHILIS TOTAL AND RPR 10/09/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
Diagnostic Direct, LLC SYPHILIS HEALTH CHECK 09/27/2021
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