MAUDE Adverse Event Report | 合法醫療器材資訊網
References
Search Alerts/Recalls
(www.fda.gov)
Catalog Number 04912551190
Device Problem High Test Results
(2457)
Patient Problem No Consequences Or
Impact To Patient (2199)
Event Date 06/22/2018
Event Type malfunction
Manufacturer Narrative
This event occurred in (b)(6).
Event DescriptionThe customer complained of high results for 1 patient tested for d-di2 tina-quant d-dimer gen.2 (d-di2) on a cobas integra 400 plus.On (b)(6) 2018 the patient was initially tested on the integra 400 plus instrument with ...
COBAS INTEGRA Tina-quant a D-Dimer COBAS INTEGRA Tina-quant a D-Dimer 光固化 PLA uv固化樹脂 光固化材料 “米榭”席伊植牙系統 聯合骨科評價 聯合骨科營收 唯晶科技股份有限公司ptt Chemistry analyzer
1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
510(k) Premarket Notification | 合法醫療器材資訊網
MAUDE Adverse Event Report | 合法醫療器材資訊網
Tina-quant@ D | 合法醫療器材資訊網
List_serum indices_Integra_V24 | 合法醫療器材資訊網
Specific Protein Portfolio | 合法醫療器材資訊網
Standard Operating Procedure References Applicable To Detail | 合法醫療器材資訊網
ROCHE DIAGNOSTICS TINA | 合法醫療器材資訊網
upload | 合法醫療器材資訊網
相關資訊整理
【羅氏可霸斯印諦快泰能康 D-D 雙合試驗生化檢驗試劑】許可證字號:衛署醫器輸字第012396號
器材品名:羅氏可霸斯印諦快泰能康D-D雙合試驗生化檢驗試劑許可證字號:衛署醫器輸字第012396號註銷狀態:已註銷註銷日期:2018/...