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cobas TaqScreen MPX Test, version 2.0 / 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法)

国药准字SJ20181014 · 体外诊断试剂

Statutory filing line: 2027-06-29

The certificate expires 2027-12-29. Under the Provisions for Drug Registration (药品注册管理办法) Art. 82, an application to renew is filed no later than 6 months before expiry.

Approval number (批准文号)国药准字SJ20181014
Generic name (通用名)cobas TaqScreen MPX Test, version 2.0
乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法)
Marketing Authorisation Holder (上市许可持有人)Roche Molecular Systems, Inc.
United States
Certificate valid until (有效期至)2027-12-29
Filing line, Art. 82 (法定申报时限)2027-06-29
Data as of (数据快照日)2026-06-28
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Every figure above is taken from the public NMPA overseas-drug database (境外生产药品库) as of 2026-06-28, or computed from it under Art. 82. Registration data changes; the NMPA portal governs. This page states no view on whether this product’s Domestic Responsible Person (境内责任人) arrangement meets NMPA Announcement No. 137 — that cannot be determined from a single public entry.