乳酸脫氫酶測(cè)定試劑盒（乳酸底物法）

貝克曼庫(kù)爾特實(shí)驗(yàn)系統(tǒng)（蘇州）有限公司

蘇械注準(zhǔn)20162400337

蘇州工業(yè)園區(qū)蘇虹西路181號(hào)

2021-04-22

2025-06-30

R1：甲基葡萄糖胺 127.0 g/L， 乳酸鋰 9.60 g/L。 R2：β-煙酰胺腺嘌呤二核苷酸 26.5 g/L

用于體外定量檢測(cè)人血清中的乳酸脫氫酶的含量。

2021-04-22產(chǎn)品儲(chǔ)存條件和/或有效期變更 由“未開(kāi)封的試劑貯存于2–8℃，其穩(wěn)定性可達(dá)瓶子標(biāo)簽上所注明的效期（18個(gè)月）。開(kāi)封后，在不超過(guò)效期的情況下，在儀器上可保持穩(wěn)定30天?！弊兏鼮椤拔撮_(kāi)封的試劑貯存于2–8℃，其穩(wěn)定性可達(dá)瓶子標(biāo)簽上所注明的效期（18個(gè)月）。開(kāi)封后，在不超過(guò)效期的情況下，在儀器上可保持穩(wěn)定21天。”對(duì)產(chǎn)品說(shuō)明書(shū)和/或產(chǎn)品技術(shù)要求中文字的修改，但不涉及技術(shù)內(nèi)容的變更 由“說(shuō)明書(shū)：【檢驗(yàn)方法】3.儀器校準(zhǔn)：使用貝克曼庫(kù)爾特AU生化分析系統(tǒng)專用校準(zhǔn)品（Cat. No. 66300）。在按照優(yōu)良實(shí)驗(yàn)室規(guī)范 （GLP）進(jìn)行校準(zhǔn)之后，應(yīng)立即進(jìn)行質(zhì)量控制程序。校準(zhǔn)品值可溯源到IFCC 參考方法和 IRMM/IFCC-453。在更換分析儀的關(guān)鍵部件時(shí)，建議重新進(jìn)行校準(zhǔn)。在換用新批次的試劑時(shí)，建議進(jìn)行試劑空白測(cè)定。5.數(shù)據(jù)計(jì)算：貝克曼庫(kù)爾特AU生化分析系統(tǒng)自動(dòng)計(jì)算各樣本乳酸脫氫酶濃度?！緟⒖嘉墨I(xiàn)】1.tThomas L. Lactate dehydrogenase (LD).In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/ Main: THBooks Verlagsgesellschaft, 1998:89-94.2.tTietz NW, ed. Clinical guide to laboratory tests, 3rd ed. Philadelphia:WB Saunders Company,1995:385pp.3.tMoss DW, Henderson RA.Clinical enzymology.In: Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company, 1999;668-673.4.tBais R, Philcox M. International Federation of Clinical Chemistry (IFCC) Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC method for lactate dehydrogenase. Eur J Clin Chem Clin Biochem 1994;32:639-55.5.tEhret W, Heil W, Schmitt Y, T？pfer G, Wisser H, Zawta B, et al.Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples.WHO/DIL/LAB/99.1 Rev.2:36pp.6.tSchumann G, Klauke R. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum:preliminary upper reference limits obtained in hospitalised subjects. Clin Chim Acta 2003;327:69-79.7.tPainter PC, Cope JY, Smith JL.Reference information for the clinical laboratory.In:Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry.Philadelphia:WB Saunders Company, 1999;1822pp.8.tYoung DS.Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000. 9.tTietz, N. W., Clinical Guide to Laboratory Tests, 3rd Edition, W. B. Saunders, Philiadelphia, PA 1995.”變更為“說(shuō)明書(shū)：【檢驗(yàn)方法】3.儀器校準(zhǔn)：使用貝克曼庫(kù)爾特AU生化分析系統(tǒng)專用校準(zhǔn)品（Cat. No. 66300）。在按照優(yōu)良實(shí)驗(yàn)室規(guī)范 （GLP）進(jìn)行校準(zhǔn)之后，應(yīng)立即進(jìn)行質(zhì)量控制程序。校準(zhǔn)品值可溯源到IFCC 參考方法和 IRMM/IFCC-453。對(duì)分析儀進(jìn)行了重要的預(yù)防性維護(hù)或更換了關(guān)鍵部件，請(qǐng)重新進(jìn)行校準(zhǔn)。換瓶，換試劑批次或質(zhì)控值顯著變化時(shí)，請(qǐng)重新進(jìn)行校準(zhǔn)。5.數(shù)據(jù)計(jì)算：貝克曼庫(kù)爾特AU生化分析系統(tǒng)自動(dòng)計(jì)算各樣本乳酸脫氫酶活性?！緟⒖嘉墨I(xiàn)】1.tThomas L. Lactate dehydrogenase (LD).In: Thomas L, ed. Clinical laboratory diagnostics. Use and assessment of clinical laboratory results. Frankfurt/ Main: THBooks Verlagsgesellschaft, 1998:89-94.2.tTietz NW, ed. Clinical guide to laboratory tests, 3rd ed. Philadelphia:WB Saunders Company,1995:385pp.3.tMoss DW, Henderson RA.Clinical enzymology.In: Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry. Philadelphia: WB Saunders Company, 1999;668-673.4.tBais R, Philcox M. International Federation of Clinical Chemistry (IFCC) Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC method for lactate dehydrogenase. Eur J Clin Chem Clin Biochem 1994;32:639-55.5.tEhret W, Heil W, Schmitt Y, T？pfer G, Wisser H, Zawta B, et al.Use of Anticoagulants in Diagnostic Laboratory Investigations and Stability of Blood, Plasma and Serum Samples.WHO/DIL/LAB/99.1 Rev.2:36pp.6.tSchumann G, Klauke R. New IFCC reference procedures for the determination of catalytic activity concentrations of five enzymes in serum:preliminary upper reference limits obtained in hospitalised subjects. Clin Chim Acta 2003;327:69-79.7.tPainter PC, Cope JY, Smith JL.Reference information for the clinical laboratory.In:Burtis CA, Ashwood ER, eds.Tietz textbook of clinical chemistry.Philadelphia:WB Saunders Company, 1999;1822pp.8.tYoung DS.Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.”

蘇州工業(yè)園區(qū)蘇虹西路181號(hào)

R1:4×40mL+R2:4×20mL

未開(kāi)封的試劑貯存于2–8℃，其穩(wěn)定性可達(dá)瓶子標(biāo)簽上所注明的效期（18個(gè)月）。開(kāi)封后，在不超過(guò)效期的情況下，在儀器上可保持穩(wěn)定21天。

第二類

原注冊(cè)證號(hào)蘇械注準(zhǔn)20162400337。