Binx Health, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1626-2023Class IIbinx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis andMarch 29, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K200533binx io CT/NG Assay and binx io CT/NG SystemApril 27, 2020
K191352binx health io CT/NG AssayAugust 8, 2019