FDA-Device2018-12-26Class II
ultra2 Genesys Variants Analyzer, REF 03-01-0045 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
14 devices
Manufactured in
2823 Girts Rd, Jamestown, NY, United States
Products
ultra2 Genesys Variants Analyzer, REF 03-01-0045 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-0620-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief