FDA-Device2018-12-26Class II
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Hazard
lack of 510K
Sold states
IL, WV, NJ, AZ, MD, UT
Affected count
252 units
Manufactured in
2823 Girts Rd, Jamestown, NY, United States
Products
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0622-2019Don't want to check this manually?
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