| 2024-04-22 |
Class II
|
Ongoing |
Z-2034-2024 |
Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biote… |
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Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-2033-2024 |
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Str… |
— |
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-2032-2024 |
Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medi… |
— |
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-2031-2024 |
Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part N… |
— |
Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-2030-2024 |
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 |
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Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi… |