510(k) Premarket Notification | 合法醫療器材資訊網
...system,test,antibodies,b2-glycoproteini(b2-gpi)22.510(k)Number,K040449.DeviceName,VARELISAB2GLYCOPROTEINIIGGANTIBODIES,MODELS ...
References Products Classification Database Information for Latex Patient Examination Glove (www.accessdata.fda.gov) Code of Federal Regulations (CFR) database information for 880.6250 (www.accessdata.fda.gov) PDF for K040448 (www.accessdata.fda.gov) Device Classification Name latex patient examination glove[1] 510(k) Number K040448 Device Name GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM Applicant...
Varelisa β2-Glycoprotein I IgG Antibodies Varelisa β2-Glycoprotein I IgG Antibodies “PENTAX”PBLADE Rigid Laryngoscope (Sterile) 長欣生技口罩評價 HWA MEEI 全寧股份有限公司 偉平貿易有限公司 杏恩念珠菌檢測試劑盒 (未滅菌) 九州企業集團醫療口罩 丸 龜 製套 門市
510(k) Premarket Notification | 合法醫療器材資訊網
... system,test,antibodies,b2 - glycoprotein i (b2 - gpi)22. 510(k) Number, K040449. Device Name, VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS ... Read More
REVIEW MEMORANDUM | 合法醫療器材資訊網
The Varelisa Cardiolipin IgG/IgM and β2-Glycoprotein I IgG/IgM. Antibodies EIA kits are designed for the semi-quantitative and qualitative determination of. IgG/IgM ... Read More
9. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | 合法醫療器材資訊網
Varelisa B2-Glycoprotein I Antibodies Screen is an indirect noncompetitive enzyme ... of IgM, IgG and IgA antibodies against 32-glycoprotein I in serum. Read More
510(k) Premarket Notification | 合法醫療器材資訊網
... system,test,antibodies,b2 - glycoprotein i (b2 - gpi)22. 510(k) Number, K040449. Device Name, VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS ... Read More
凡立沙β2醣蛋白I IgG抗體檢測試劑Varelisa β2 | 合法醫療器材資訊網
凡立沙β2醣蛋白I IgG抗體檢測試劑Varelisa β2-Glycoprotein I IgG Antibodies / Varelisa β2-醣蛋白類I IgG 抗體(β2-glycoprotein I IgG antibodies)的診斷試劑盒是用 ... Read More
MSV | 合法醫療器材資訊網
K040449, VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 ... K030701, IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA ... Read More
K oqoqqq | 合法醫療器材資訊網
Varelisa® B2 Glycoprotein I IgG Antibodies. Common Name: ... The Varelisa 032 -Glycoprotein I IgG Antibodies EIA kit is designed for the semiquantitative and ... Read More
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ... | 合法醫療器材資訊網
1. Intended use(s):. The Varelisa B2-Glycoprotein I Antibodies Screen Kit is designed for the qualitative determination of β2-glycoprotein I antibodies in serum or plasma. 2. Indication(s) for use: ... Anti-human IgG, IgA, IgM. Antibody Conjugate,. Read More
Evaluation of anticardiolipin antibodies in tobacco users and ... | 合法醫療器材資訊網
由 PK Yadalam 著作 · 2016 · 被引用 5 次 — ELISA kits from Sweden Diagnostics kit, Varelisa IgM Cardiolipin Antibodies, and Varelisa β2-Glycoprotein 1 (IgG) Antibodies were used to ... Read More
相關資訊整理
【凡立沙β2醣蛋白 I IgG抗體檢測試劑】許可證字號:衛署醫器輸字第014803號
器材品名:凡立沙β2醣蛋白IIgG抗體檢測試劑許可證字號:衛署醫器輸字第014803號註銷狀態:已註銷註銷日期:2017/04/21註銷理由:...