FDA-Device2018-12-26Class II
Genesys Analytical Column, REF 01-05-0017 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
372 units
Manufactured in
2823 Girts Rd, Jamestown, NY, United States
Products
Genesys Analytical Column, REF 01-05-0017 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-0621-2019Don't want to check this manually?
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