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InBios International, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories4
Latest FDA decision2025-10-12
TypeNumberDevice NameCodeDateActions
510(k) K251595 COVID-19 Detect Rapid Self -TestQYT2025-10-12 View
510(k) K233358 SCoV-2 Ag Detect Rapid TestQVF2024-08-23 View
510(k) K181473 DENV Detect NS1 ELISAQCU2018-08-27 View
510(k) K161947 Chagas Detect Plus Rapid TestMIU2016-12-16 View