510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
RocheCobasIntegraAmikacinAssay.2.PredicateKnumber(s):.K991597.3.Comparisonwithpredicate:Thefundamentaltestprincipleemployeddiffersinthe ...
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COBAS INTEGRA Amikacin COBAS INTEGRA Amikacin Medtronic Cryoablation 羊膜穿刺針 IBL Epstein-Barr-Virus VCA IgM "HEJIE" TONGUE DEPRESSOR (Sterile/Non-Sterile) 全口x光機價格 牙科電腦斷層 長振儀器股份有限公司 Planmeca promax 3d
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
Roche Cobas Integra Amikacin Assay. 2. Predicate K number(s):. K991597. 3. Comparison with predicate: The fundamental test principle employed differs in the ... Read More
Order information Analyzer(s) on which cobas c pack(s) can ... | 合法醫療器材資訊網
Intended use. In vitro test for the quantitative determination of amikacin in serum and ... analyzer (x) and on a COBAS INTEGRA 700 analyzer (x). Roche/Hitachi ... Read More
Roche ONLINE TDM Amikacin | 合法醫療器材資訊網
Classification name: Amikacin serum assay. 3) Predicate device. We claim substantial equivalence to the currently marketed COBAS. INTEGRA Amikacin (K99 ... Read More
Roche ONLINE TDM Amikacin | 合法醫療器材資訊網
Classification name: Amikacin serum assay. 3) Predicate device. We claim substantial equivalence to the currently marketed COBAS. INTEGRA Amikacin (K99 ... Read More
Therapeutic drug monitoring (TDM) Portfolio | 合法醫療器材資訊網
Assays · Acetaminophen - ACETA · Amikacin - AMIK · Carbamazepine - CARB · Cyclosporin Total - CSA · Digoxin - DIG · Everolimus - EVL (cobas e) · Gabapentin - ... Read More
Therapeutic Drug Monitoring in the COBAS Integra 400 ... | 合法醫療器材資訊網
由 J Hermida 著作 · 2001 · 被引用 8 次 — Since 1993 therapeutic monitoring of phenytoin, phenobarbital, carbamazepine, valproic acid, tobramycin, vancomycin, and amikacin has been carried out in our ... Read More
Therapeutic drug monitoring on COBAS INTEGRA ... | 合法醫療器材資訊網
由 I Domke 著作 · 2000 · 被引用 15 次 — The COBAS INTEGRA 400 (Roche Diagnostics GmbH) is a random access ... Amikacin/ Phenytoin/ Free Phenytoin/ Lidocaine (fluorescence polarization ... Read More
Therapeutic drug monitoring on COBAS INTEGRA 400 ... | 合法醫療器材資訊網
For Acetaminophen and Amikacin COBAS INTEGRA 700 was used as additional comparison instrument. The results are summarized in a table (table 6). Read More
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器材品名:羅氏可霸斯印諦快丁胺卡那霉素生化檢驗試劑許可證字號:衛署醫器輸字第013043號註銷狀態:註銷日期:註銷理由:有效日...