FDA-Device2015-04-01Class III
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Roche Molecular Systems, Inc.
Hazard
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Sold states
Foreign
Affected count
190 kits
Manufactured in
1080 Us Highway 202 S, Branchburg, NJ, United States
Products
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2015Don't want to check this manually?
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