Roche launches Elecsys Epstein | 合法醫療器材資訊網
2021年3月31日—RochewillfileforapprovalwiththeFDAinthefuture.TheElecsys®EBVpanelconsistsofthreeimmunoassays:ElecsysEBVIgM,ElecsysEBV ...
2021年3月31日 — Roche will file for approval with the FDA in the future. The Elecsys® EBV panel consists of three immunoassays: Elecsys EBV IgM, Elecsys EBV ...
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cobas® EBV | 合法醫療器材資訊網
cobas® EBV is an in vitro nucleic acid amplification test for the quantification of Epstein-Barr virus (EBV) DNA in human EDTA plasma. cobas® EBV is intended for ... Read More
Diagnostics | 合法醫療器材資訊網
cobas® EBV EBNA IgG. EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to ... Read More
Elecsys® EBV panel | 合法醫療器材資訊網
Immunoassays for the qualitative detection of specific antibodies to Epstein-Barr virus (EBV) Read More
Roche announces FDA authorisation for the first ... | 合法醫療器材資訊網
2020年8月5日 — The cobas EBV test is a real-time PCR (polymerase chain reaction) viral load test with dual target technology, which provides quantitative ... Read More
Roche announces FDA authorisation for the first Epstein | 合法醫療器材資訊網
FDA granted de novo class II for cobas EBV test following the agency's Breakthrough Device designation. Accurate monitoring of Epstein-Barr virus DNA levels ... Read More
Roche launches cobas EBV and BKV Tests on the cobas ... | 合法醫療器材資訊網
The cobas® EBV (Epstein-Barr virus) and cobas® BKV (BK virus) Tests provide reliable, standardized, high-quality results for clinical decision-making to help ... Read More
Roche launches Cobas EBV | 合法醫療器材資訊網
December 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas ... Read More
Roche launches Elecsys Epstein | 合法醫療器材資訊網
2021年3月31日 — Roche will file for approval with the FDA in the future. The Elecsys® EBV panel consists of three immunoassays: Elecsys EBV IgM, Elecsys EBV ... Read More
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【羅氏可霸斯全自動EBV核酸檢驗組】許可證字號:衛部醫器輸字第033523號
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