FDA-Device2020-04-29Class II
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Carolina Liquid Chemistries Corp
Hazard
Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
Sold states
U.S.: NC, TX, FL, NY, AZ, NJ, NH, CA
Affected count
90 test kits/devices
Manufactured in
510 W Central Ave Ste C, N/A, Brea, CA, United States
Products
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1743-2020Don't want to check this manually?
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