肌酐檢測試劑盒(終點法)

肌酐檢測試劑盒(終點法)

東軟威特曼生物科技（南京）有限公司

蘇械注準(zhǔn)20172400216

南京市雨花臺區(qū)西善橋南路108號2號樓

2025-06-13

2027-02-23

試劑1：肌酸酶(CR) 24000 U/L，肌氨酸氧化酶(SOX)11000 U/L。 試劑2：肌酐酶(CRN) 250000 U/L，4-氨基安替吡啉(4-AAP)0.61 g/L。 注：不同批號之間的各組分不可以互換。

用于人血清或血漿中肌酐含量的體外定量測定。

2025-06-13包裝規(guī)格變更 由“80mL/盒(R1:1×60mL、R2:1×20mL；R1:2×30mL、R2:1×20mL）100mL/盒(R1:1×75mL、R2:1×25mL；R1:2×37.5mL、R2:1×25mL；R1:3×25mL、R2:2×12.5mL)160mL/盒(R1:2×60mL、R2:2×20mL；R1:3×40mL、R2:2×20mL)200mL/盒(R1:2×75mL、R2:2×25mL；R1:3×50mL、R2:1×50mL；R1:4×37.5mL、R2:2×25mL；R1:2×75mL、R2:1×50mL；R1:6×25mL、R2:4×12.5mL ； R1:3×50mL、R2:2×25mL)240mL/盒(R1:5×36mL、R2:3×20mL；R1:4×45mL、R2:3×20mL； R1:3×60mL、R2:3×20mL）300mL/盒(R1:3×75mL、R2:3×25mL；R1:5×45mL、R2:3×25mL；R1:5×45mL、R2:2×37.5mL；R1:3×75mL、R2:1×75mL ；R1:6×37.5mL、R2:3×25mL）”變更為“80mL/盒 (R1:1×60mL、R2:1×20mL； R1:2×30mL、R2:1×20mL） 100mL/盒 (R1:1×75mL、R2:1×25mL； R1:2×37.5mL、R2:1×25mL； R1:3×25mL、R2:2×12.5mL) 160mL/盒 (R1:2×60mL、R2:2×20mL； R1:3×40mL、R2:2×20mL） 200mL/盒 (R1:2×75mL、R2:2×25mL； R1:3×50mL、R2:1×50mL； R1:4×37.5mL、R2:2×25mL； R1:2×75mL、R2:1×50mL； R1:6×25mL、R2:4×12.5mL ； R1:3×50mL、R2:2×25mL） 240mL/盒 (R1:5×36mL、R2:3×20mL； R1:4×45mL、R2:3×20mL； R1:3×60mL、R2:3×20mL） 300mL/盒 (R1:3×75mL、R2:3×25mL； R1:5×45mL、R2:3×25mL； R1:5×45mL、R2:2×37.5mL； R1:3×75mL、R2:1×75mL ； R1:6×37.5mL、R2:3×25mL) 300測試/盒、600測試/盒、900測試/盒、1200測試/盒”適用儀器變化 由“奧林巴斯 AU400、奧林巴斯 AU2700、貝克曼AU480、貝克曼AU680、貝克曼AU5800、日立7080、日立7180、日立7600、雅培ARCHITECT c8000、東芝TBA-120FR、東芝TBA-2000FR、東芝TBA-FX8、羅氏COBAS C501、羅氏COBAS C701、邁瑞B(yǎng)S-350E、邁瑞B(yǎng)S-480、邁瑞B(yǎng)S-800、東軟NT-1000、東軟NT-480、西門子ADVIA 1800、西門子ADVIA 2400、西門子 ADVIA XPT、迪瑞CS-400B、迪瑞CS-600B、迪瑞CS-1200、勞拉FAITH 4060、科華ZY-1280、神州英諾華D-360、雷杜 Chemray 800、優(yōu)利特URIT 8600、藍(lán)韻LW C400、博科BK-400、頤蘭貝ES-480全自動生化分析儀。”變更為“貝克曼AU640、貝克曼AU2700、貝克曼AU5400、貝克曼AU480、貝克曼AU680、貝克曼AU5800、日立7180、日立7100、日立7080、日立7600、日立3500、日立LABOSPECT 008AS、日立LABOSPECT 006、東芝TBA120FR、東芝TBA2000FR、東芝TBA-FX8、佳能TBA-120FR、佳能TBA-2000FR、佳能TBA-FX8、雅培ARCHITECT c8000、雅培ARCHITECT c16000、羅氏cobas 8000、羅氏cobas 501、羅氏cobas 502、羅氏cobas 701、羅氏cobas 702、東軟威特曼NT-420、東軟威特曼NT-480、東軟威特曼NT-480P、東軟威特曼NT-1000、東軟威特曼NT-1000P、邁瑞B(yǎng)S480、邁瑞B(yǎng)S600、邁瑞B(yǎng)S800、邁瑞B(yǎng)S2000、邁瑞B(yǎng)S2800M、西門子ADVIA 1800、西門子ADVIA2400、西門子ADVIA Chemistry XPT、西門子Atellica Solution CH930、迪瑞CS-480、迪瑞CS-680、迪瑞CS-1200、迪瑞CS-1300、迪瑞CS-1600、迪瑞CS-2000、科華卓越ZY-1280、頤蘭貝ES—480、優(yōu)利特URIT 8600全自動生化分析儀。”產(chǎn)品技術(shù)要求、說明書變化變更由“技術(shù)要求、說明書變更情況對比表原條款及內(nèi)容”變更為“技術(shù)要求、說明書變更情況對比表修改后條款及內(nèi)容”

南京市雨花臺區(qū)西善橋南路108號2號樓

80mL/盒 (R1:1×60mL、R2:1×20mL； R1:2×30mL、R2:1×20mL) 100mL/盒 (R1:1×75mL、R2:1×25mL； R1:2×37.5mL、R2:1×25mL； R1:3×25mL、R2:2×12.5mL) 160mL/盒 (R1:2×60mL、R2:2×20mL； R1:3×40mL、R2:2×20mL) 200mL/盒 (R1:2×75mL、R2:2×25mL； R1:3×50mL、R2:1×50mL； R1:4×37.5mL、R2:2×25mL； R1:2×75mL、R2:1×50mL； R1:6×25mL、R2:4×12.5mL ； R1:3×50mL、R2:2×25mL) 240mL/盒 (R1:5×36mL、R2:3×20mL； R1:4×45mL、R2:3×20mL； R1:3×60mL、R2:3×20mL) 300mL/盒 (R1:3×75mL、R2:3×25mL； R1:5×45mL、R2:3×25mL； R1:5×45mL、R2:2×37.5mL； R1:3×75mL、R2:1×75mL ； R1:6×37.5mL、R2:3×25mL) 300測試/盒、600測試/盒、900測試/盒、1200測試/盒

試劑于2~8℃避光保存可穩(wěn)定一年。開瓶后可穩(wěn)定一個月。

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