Device product
Matrix Clinical Solution At-Home COVID-19 Test
Z-0947-2022
Product summary
- Event
- Event 89511
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,226 kits
- Official record key
device-enforcement:Z-0947-2022
Official wording
Reason: Due to COVID-19 Test not being authorized for home sample collection.
Code information: Product Number SKU: 15206 All Test Kits No Lot Numbers
Distribution pattern: U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV. O.U.S.: N/A
Derived failure modes
-
Unknown
Due to COVID-19 Test not being authorized for home sample collection.