Class 2 Device Recall Atellica IM antiCCP IgG (aCCP) Assay | 合法醫療器材資訊網
2019年9月26日—SiemensMaterialNumber:10732998(100Test)TestVersion1.0-ProductUsage:TheADVIACentaur¿Anti-CCPIgG(aCCP)assayisforin ...
References Related Medical Device Recalls (www.accessdata.fda.gov) K153551 (www.accessdata.fda.gov) Antibodies, anti-cyclic citrullinated peptide (ccp) (www.accessdata.fda.gov) NHX (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 = NHX and Original Applicant = Axis-Shield Diagnostics Limited. (www.accessdata.fda.gov) Date Initiated by Firm August 14, 2019 Create Date September 26, 2019 Recall Status1 ...
ADVIA Centaur aCCP Assay ADVIA Centaur aCCP Assay 宏基醫療器材行 “必是恩”醫療用黏性膠帶及黏性繃帶(未滅菌) 利多牙材 生理監測器飛利浦 konsyl pharmaceuticals sitzmarks sitzmarks capsule purchase Instrumentation Laboratory “DA
REVIEW MEMORANDUM | 合法醫療器材資訊網
由 C Measurand 著作 — Precision: The precision of the ADVIA Centaur aCCP assay was evaluated by testing eight serum samples containing various concentrations of anti-CCP antibody. Read More
Class 2 Device Recall Atellica IM antiCCP IgG (aCCP) Assay | 合法醫療器材資訊網
2019年9月26日 — Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in ... Read More
August 4 | 合法醫療器材資訊網
2016年8月4日 — Trade/Device Name: ADVIA Centaur® Anti-CCP IgG (aCCP) Assay ... precision and accuracy of the ADVIA Centaur aCCP assay using the ... Read More
ADVIA Centaur XP | 合法醫療器材資訊網
ADVIA Centaur XP Immunoassay SystemHow does your lab meet varied testing demands? · High throughput, up to 240 tests/hour · Intuitive software for ease of ... Read More
Immunoassay | 合法醫療器材資訊網
Performance of the ADVIA Centaur® Vitamin D Total Assay Standardized to Reference ... The aCCP assay on the IMMULITE® 2000 XPi has good performance ... Read More
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