FDA-Device2015-01-28Class III
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
Roche Molecular Systems, Inc.
Hazard
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Sold states
Foreign Distributed.
Affected count
660 pieces
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2015Don't want to check this manually?
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