For in vitro diagnostic use. Others FEN2 IVD FEN2 CPS_001030 Fentanyl II Enzyme Immunoassay 09 310 002 190 9 310 002 190 09310002190 9310002190 09310002190 FEN2, 200T, cobas c, PCh FEN2 00850624008254 Reagents, kits 200 tests cobas c 501/502 true 10 427 531 190 10427531190 FEN2, 850T, cobas c pack green, PCh FEN2, 850T, cobas c pack green, PCh 00850624008643 Reagents, kits 850 tests cobas c 303/503/703 true 09 444 360 190 9 444 360 190 09444360190 9444360190 09444360190 FEN2, 240T, cobas c pack green, PCh FEN2 Reagents, kits 240 tests cobas c 303/501/502/503 undefined 0109310002190c501 FEN2 Fentanyl II Enzyme Immunoassay en 4 C1000000000C0C0E FF00000004B7590E 09310002190 309 cobas c 501 2324 cobas c 502 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended use The Fentanyl II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative determination of norfentanyl in human urine at a cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for screening with the Roche cobas c 501/502 automated clinical chemistry analyzers.The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/ Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.ReferencesReferences Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0209310002190c501 FEN2 Fentanyl II Enzyme Immunoassay en 1 FF000000051AE90E FF000000051AE80E 09310002190 309 cobas c 501 2324 cobas c 502 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Fentanyl II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative determination of norfentanyl in human urine. The cutoff for the assay is 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use on Roche cobas c analyzers. The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).,LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0109310002190c501 FEN2 Fentanyl II Enzyme Immunoassay en 2 FF000000059D6F0E FF00000004DE140E 09310002190 309 cobas c 501 2324 cobas c 502 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Fentanyl II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative determination of norfentanyl in human urine. The cutoff for the qualitative mode of the assay is 5 ng/mL for norfentanyl. The assay is designed for prescription use on Roche cobas c analyzers. The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).,LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0210427531190c503 FEN2 Fentanyl II Enzyme Immunoassay en 2 C10000000008090E FF00000007A25A0E 10427531190 9493 cobas c 303 8481 cobas c 503 10299 cobas c 703 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended use The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at a cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result.ReferencesReferences Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0110427531190c503 FEN2 Fentanyl II Enzyme Immunoassay en 1 FF00000007A4240E FF00000007A4230E 10427531190 9493 cobas c 303 8481 cobas c 503 10299 cobas c 703 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended use The Fentanyl II Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative determination of norfentanyl in human urine at a cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for screening with the Roche cobas c 503/303/703 automated clinical chemistry analyzers.The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC-MS or LC-MS) are the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en 0209444360190c503 FEN2 Fentanyl II Enzyme Immunoassay en 3 FF00000007600F0E FF000000056EFC0E 09444360190 9493 cobas c 303 8481 cobas c 503 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended use The LZI Fentanyl II Enzyme Immunoassay is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. en

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