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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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159 records meeting your search criteria returned- Product Code: QKP Product Problem: Product Quality Problem Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
MAXIM BIOMEDICAL INC. MAXIMBIO CLEARDETECT COVID TEST 11/17/2022
MAXIM BIOMEDICAL INC MAXIMBIO CLEARDETECT COVID TEST 11/17/2022
IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANITIGEN RAPID TEST SEL 11/14/2022
IHEALTH MANUFACTURING INC. IHEALTH COVID-19 ANITIGEN RAPID TEST SEL 11/14/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
IHEALTH LABS INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 10/25/2022
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