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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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81 records meeting your search criteria returned- Product Code: QKP Product Problem: Device Markings/Labelling Problem Report Date From: 01/1/2019

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ManufacturerBrand NameDate Report Received
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/15/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/15/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/15/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 07/15/2022
IHEALTH / ANDON MEDICAL CO., LTD. IHEALTH COVID 19 ANTIGEN RAPID TEST 06/22/2022
IHEALTH LABS, INC. IHEALTH COVID-19 ANTIGEN RAPID TEST 05/31/2022
BD RAPID DIAGNOSTICS (SUZHOU) CO. LTD. VERITOR AT-HOME COVID-19 DIGITAL TEST KI 05/13/2022
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR 04/04/2022
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR 03/16/2022
BECTON, DICKINSON & CO. (SPARKS) BD MAX SARS-COV-2 REAGENTS KIT 03/10/2022
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