FDA-Device2024-06-19Class II
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Wondfo USA Co Ltd
Hazard
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.
Sold states
US Nationwide distribution.
Affected count
170,000 units
Manufactured in
545 Willowbrook Center Pkwy Ste B, N/A, Willowbrook, IL, United States
Products
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2031-2024Don't want to check this manually?
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