Class 2 Device Recall Roche Diagnostics Tinaquant IgM Gen.2 | 合法醫療器材資訊網
2019年4月13日—forRecall,Newendogenousinterferenceclaimshavebeenestablishedforthefollowingassaysusedonthecobasc311analyzerandthe ...
References Related Medical Device Recalls (www.accessdata.fda.gov) K040431 (www.accessdata.fda.gov) Igg (fd fragment specific), antigen, antiserum, control (www.accessdata.fda.gov) DAQ (www.accessdata.fda.gov) TPLC Device Report (www.accessdata.fda.gov) medical device recalls (www.fda.gov) Code of Federal Regulations (CFR) Title 21 §7.55 (www.accessdata.fda.gov) 510(K)s with Product Code = DAQ and Original Applicant = ROCHE DIAGNOSTICS CORP. (www.accessdata.fda.gov) Date Initiated by Firm December 17, 2018 Date Posted ...
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can be used 03507190 190 Tina | 合法醫療器材資訊網
03507190 190 Tina-quant IgM Gen.2 (150 tests). System‑ID 07 6788 3. Roche/Hitachi cobas c 311, cobas c 501/502. 11355279 216 Calibrator f.a.s. Proteins (5 ... Read More
Class 2 Device Recall Roche Diagnostics Tinaquant IgM Gen.2 | 合法醫療器材資訊網
2019年4月13日 — for Recall, New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the ... Read More
cobas c IGM | 合法醫療器材資訊網
標籤: cobas c IGM-2. 【羅氏可霸斯泰能康免疫球蛋白M第二代檢驗試劑】許可證字號:衛署醫器輸字第023467號. 器材品名:羅氏可霸斯泰能康免疫球蛋白M第二代. Read More
cobas® pro integrated solutions | 合法醫療器材資訊網
24 hour uninterrupted operation2; Continuous loading of reagents and ... With up to 6 months of onboard stability for the cobas c pack green, and up to 4 months ... Read More
Elecsys® Anti-SARS-CoV | 合法醫療器材資訊網
Rothe, C. et al. (2020). N Engl J Med. 382(10), 970-971. Kupferschmidt, K. Study claiming new coronavirus ... Read More
Order information Analyzer(s) on which cobas c pack(s) can ... | 合法醫療器材資訊網
Analyzer(s) on which cobas c pack(s) can be used. 03507190 190 Tina-quant IgM Gen.2 150 tests. System‑ID 07 6788 3. Roche/Hitachi cobas c 311, cobas c ... Read More
Tina | 合法醫療器材資訊網
measurement of a sample blank minimizes interference effects. 1 of 2 ... 2. Tina-quant® Immunoglobulin G Gen. 2. Analyzer compatibility cobas c 311 analyzer. Read More
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【羅氏可霸斯泰能康免疫球蛋白M第二代檢驗試劑】許可證字號:衛署醫器輸字第023467號
器材品名:羅氏可霸斯泰能康免疫球蛋白M第二代檢驗試劑許可證字號:衛署醫器輸字第023467號註銷狀態:註銷日期:註銷理由:有效日...
【羅氏可霸斯免疫球蛋白M第二代檢驗試劑】許可證字號:衛署醫器輸字第021400號
器材品名:羅氏可霸斯免疫球蛋白M第二代檢驗試劑許可證字號:衛署醫器輸字第021400號註銷狀態:已註銷註銷日期:2018/05/28註銷...
【羅氏可霸斯免疫球蛋白M生化檢驗試劑第2代】許可證字號:衛署醫器輸字第024092號
器材品名:羅氏可霸斯免疫球蛋白M生化檢驗試劑第2代許可證字號:衛署醫器輸字第024092號註銷狀態:註銷日期:註銷理由:有效日期:...