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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
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69 records meeting your search criteria returned- Product Code: QKP Product Problem: Defective Device Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 11/28/2022
IHEALTH LABS INC. /IHEALTH MANUFACTURING IHEALTH COVID-19 ANTIGEN RAPID TEST 11/14/2022
IHEALTH LABS INC. /IHEALTH MANUFACTURING IHEALTH COVID-19 ANTIGEN RAPID TEST 11/14/2022
MAXIMBIO / MAXIM BIOMEDICAL, INC. MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HO 11/08/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/13/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/13/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 ANTIGEN HOME TEST 08/30/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 ANTIGEN HOME TEST 08/30/2022
MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 ANTIGEN HOME TEST 08/30/2022
ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST 05/26/2022
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