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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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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
 

 
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83 records meeting your search criteria returned- Product Code: QKP Patient Problem: Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
IHEALTH LABS, INC. COVID RAPID ANTIGEN TEST KIT AT HOME 02/01/2022
IHEALTH LABS, INC. COVID RAPID ANTIGEN TEST KIT AT HOME 02/01/2022
IHEALTH LABS, INC. IHEALTH AT HOME RAPID ANTIGEN COVID TEST 02/01/2022
ELLUME LIMITED ELLUME COVID-19 HOME TEST 01/07/2022
Unknown Manufacturer COVID TESTING 12/28/2021
Unknown Manufacturer COVID 19 TEST 12/28/2021
ORASURE TECHNOLOGIES INC. INTELISWAB COVID-19 RAPID TEST 12/28/2021
INNOVA MEDICAL GROUP INNOVA SARS COV2 ANTIGEN RAPID QUALITATI 12/23/2021
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST 12/20/2021
ORASURE TECHNOLOGIES INC. INTELISWAB COVID-19 RAPID TEST 11/01/2021
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