510(k) Premarket Notification | 合法醫療器材資訊網
cobas(r)coreigetotaleia23,ROCHEDIAGNOSTICSYSTEMS,INC.K93089024,08/05/1993.abuscreenonlinebenzodiazepines300calibrator25,ROCHE ...
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
Roche Abuscreen OnLine Benzodiazepines Roche Abuscreen OnLine Benzodiazepines 維特司3600免疫診斷分析儀(未滅菌) 台灣巴可裁員 巴涼科技股份有限公司 Barco Taiwan 趨勢鏡片品質 “OLYMPUS” Argon Plasma Coagulation Unit APU-300 美賓興業有限公司 "WECK" BICEPS BIPOLAR COAGULATOR
(PDF) Evaluation of Roche Abuscreen ONLINE Amphetamine ... | 合法醫療器材資訊網
PDF | Some structural analogues of amphetamine are now important drugs of abuse in Thailand. The utility of the Roche Abuscreen ONLINE reagent... | Find ... Read More
510(k) Premarket Notification | 合法醫療器材資訊網
cobas(r) core ige total eia23, ROCHE DIAGNOSTIC SYSTEMS, INC. K93089024, 08/05/1993. abuscreen online benzodiazepines 300 calibrator25, ROCHE ... Read More
A comparison of five commercial immunoassays for ... | 合法醫療器材資訊網
由 AM Barrett 著作 · 1999 · 被引用 8 次 — ... and Roche Abuscreen(R) Online(TM), all used for the benzodiazepine group ... immunoassays for the detection of flunitrazepam and other benzodiazepines ... Read More
A comparison of five commercial immunoassays for the ... | 合法醫療器材資訊網
由 AM BARRETT 著作 · 1999 · 被引用 8 次 — ... Roche Abuscreen® OnlineTM, all used for the benzodiazepine gr... ... for the detection of flunitrazepam and other benzodiazepines in urine. Read More
Detecting benzodiazepines | 合法醫療器材資訊網
由 RL Fitzgerald 著作 · 1994 · 被引用 53 次 — We tested 231 urine samples by six immunoassay methods--EMIT d.a.u., EMIT II, Roche Abuscreen Online, Abbott TDx, Diagnostic Products Corp. Read More
K043327 B. Purpose for Submi | 合法醫療器材資訊網
enzyme-labeled drug (conjugate). J. Substantial Equivalence Information: 1. Predicate device name(s):. Roche Abuscreen OnLine Benzodiazepines Assay. 2. Read More
Precision and comparability of Abuscreen OnLine assays for ... | 合法醫療器材資訊網
由 M Boettcher 著作 · 2000 · 被引用 5 次 — Abuscreen OnLine assays for drugs of abuse screening in urine have recently been developed for use on Hitachi 917 analyzers (Roche Diagnostics GmbH). ... 1.9/1.3/3.4/2.4, barbiturates 3.0/1.6/3.9/3.1, benzodiazepine Read More
Urine benzodiazepine screening using Roche ... | 合法醫療器材資訊網
由 KL Klette 著作 · 2005 · 被引用 25 次 — Performance of the Roche Online KIMS (kinetic interaction of microparticles in solution) benzodiazepine (BZD) immunoassay (IA) with and without ... Read More
Urine benzodiazepine screening using Roche ... | 合法醫療器材資訊網
由 KL Klette 著作 · 2005 · 被引用 25 次 — Performance of the Roche Online KIMS (kinetic interaction of microparticles in solution) benzodiazepine (BZD) immunoassay (IA) with and without ... Read More
羅氏自動化分析苯二氮類校正液300ngml Roche Abuscreen ... | 合法醫療器材資訊網
羅氏自動化分析苯二氮類校正液300ng/ml Roche Abuscreen ONLINE Benzodiazepines Calibrator 300ng/ml / 提供Roche自動化臨床分析儀進行人類尿液中苯二氮 ... Read More
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