FDA-Device2023-05-31Class II
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Binx Health, Inc.
Hazard
May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results
Sold states
In the US state of PA
Affected count
50 single-use cartridges
Manufactured in
245 1st St Ste 18, Riverview II, Cambridge, MA, United States
Products
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1626-2023Don't want to check this manually?
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