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 System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (www.accessdata.fda.gov) Code of Federal Regulations (CFR) database information for 866.5660 (www.accessdata.fda.gov) PDF for K040449 (www.accessdata.fda.gov) pdf of 510(k) K040449 (www.accessdata.fda.gov) Device Classification Name system,test,antibodies,b2 - glycoprotein i (b2 - gpi)[1] 510(k) Number K040449 Device Name VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS ...
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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:...