FDA-Device2022-12-14Class I
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
DEWEI MEDICAL EQUIPMENT CO LTD
Hazard
Products were distributed in the United States without FDA authorization or clearance.
Sold states
US Distribution in states to: CA, FL, KY, and MI.
Affected count
1,348,000 (US)
Manufactured in
5 Th Floor, No.4 Building,Shiyou Industrial Park, Jun'An,Shunde, Foshan, N/A, China
Products
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0323-2023Don't want to check this manually?
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