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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: QKP Product Problem: Incomplete or Missing Packaging Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
IHEALTH MANUFACTURING INC. COVID-19 ANTIGEN RAPID TEST 01/05/2023
Unknown Manufacturer RAPID ANTIGEN TEST SALIXIUM 07/19/2022
Unknown Manufacturer RAPID ANTIGEN TEST SALIXIUM 07/19/2022
Unknown Manufacturer RAPID ANTIGEN TEST SALIXIUM 07/19/2022
ANDON MEDICAL CO.,LTD IHEALTH 06/30/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN TEST 06/14/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN TEST 06/14/2022
SD BIOSENSOR, INC. COVID-19 AT-HOME TEST 05/03/2022
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