China NMPA legacy archive 沪械注准20242400042亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法)
- Device class
- Class II
- Model specifications
- See annex.
- Approval department
- Shanghai Municipal Drug Administration
- Registration number
- 沪械注准20242400042
- Approval date
- February 04, 2024
- Expiry date
- February 03, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区钦州北路1189号
本试剂盒供医疗机构用于体外定量测定人血清、血浆或尿液样本中亮氨酸氨基肽酶(LAP)的活性.作辅助诊断用.
本试剂盒供医疗机构用于体外定量测定人血清、血浆或尿液样本中亮氨酸氨基肽酶（LAP）的活性。作辅助诊断用。
试剂1(R1):Tris缓冲液;试剂2(R2):柠檬酸盐缓冲液、L-亮氨酰对硝基苯胺;校准品:人血基质、 亮氨酸氨基肽酶;质控品L:人血基质、 亮氨酸氨基肽酶;质控品H:人血基质、亮氨酸氨基肽酶.
试剂1（R1）：Tris缓冲液；试剂2（R2）：柠檬酸盐缓冲液、L-亮氨酰对硝基苯胺；校准品：人血基质、 亮氨酸氨基肽酶；质控品L：人血基质、 亮氨酸氨基肽酶；质控品H：人血基质、亮氨酸氨基肽酶。
Store at 2~8°C away from light, and the expiration date is 9 months.
2~8℃避光保存，有效期为9个月。
- Changes
- 1、产品注册证变更包装规格、有效期，详见附件1（共3页）。 2、产品技术要求变更产品规格、装量指标，详见附件2（共3页）。 3、产品说明书变更包装规格、有效期、适用仪器及其他文字性变更，详见附件3（共5页）。;本文件与“沪械注准20242400042”注册证共同使用。;2024-12-20
This static archive preserves historical registration fields and translations for 亮氨酸氨基肽酶测定试剂盒(L-亮氨酰对硝基苯胺底物法), registration 沪械注准20242400042. It does not establish current authorization or complete current product details.
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