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⚠️ 此醫材許可證已註銷
狀態:已註銷 日期:2018/05/10
原因:許可證已逾有效期
"伊姆諾康塞斯特" 可萃取核抗原自體抗體篩選酵素免疫測試試劑組
🩺 醫材"ImmunoConcepts" RELISA ENA Single Well Screening Test
衛署醫器輸字第015716號
醫材分類
第 2 等級
- C.5100抗核抗體免疫試驗系統
醫器規格
#7096-10
限制項目
輸 入
適應症
偵測可萃取核抗原(extractable nuclear antigens, ENA)人體血漿中對抗Sm(Smith)、RNP、SS-A(Ro)、SS-B(La)、Scl-70與Jo-1的抗體。
醫材資訊
- 主成分
- ENA Antigen Coated Microwell strips: Eight well strips coated with a blended of six stabilized affinity purified extractable nuclear antigens (Sm, RNP, SSA/Ro, SSB/La, Scl-70, and Jo-1).Sample diluent:Enzyme antibody reagent-Human IgG heavy and light chain specific: Coat anti-human IgG (H&L) conjugated to horseradish peroxidaseSubstrate solution: containing TMB and H2O2Stopping reagent: hydrochloric and sulfuric acid (<3%)clibrator serum: human serum with 0.1% sodium azidepositive control: human serum with 0.1% sodium azidenegative control: human serum with 0.1% sodium azideOptional ENA Undiluted Assayed Positive Control: human serum with 0.1% sodium azidePBS Buffer: Phosphate-buffered saline powder (0.01 M,)Wash Buffer Concentrate: 5% Tween 20 solution to be used in the wash buffer.
- 製造商
- IMMUNO CONCEPTS NA LTD
- 製造國
- US
- 申請商
- 泓展有限公司
- 有效日期
- 2015/12/22
- 發證日期
- 2005/12/22
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