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InBios International, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories6
Latest Approval2025-10-12
TypeNumberDevice NameCodeDate
510(k) K251595 COVID-19 Detect Rapid Self -Test QYT 2025-10-12 View
510(k) K233358 SCoV-2 Ag Detect Rapid Test QVF 2024-08-23 View
510(k) DEN220044 Active Anthrax DetectTM Plus Rapid Test QUU 2023-02-03 View
510(k) DEN180069 ZIKV Detect 2.0 IgM Capture ELISA QFO 2019-05-23 View
510(k) K181473 DENV Detect NS1 ELISA QCU 2018-08-27 View
510(k) K161947 Chagas Detect Plus Rapid Test MIU 2016-12-16 View