Device |
over-the-counter molecular test to detect sars-cov-2 from clinical specimens |
Definition |
An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments. |
Product Code | QWB |
Regulation Number |
866.3984
|
Device Class |
2
|
MDR Year |
MDR Reports |
MDR Events |
2024 |
1 |
1 |
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