230106
IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species
体外诊断 检测试剂/试剂盒、血清学、细菌、链球菌属
Oxoid Ltd.·B·Hong Kong MDACS·Registered March 22, 2023
Device overview
- Risk class
- B
- Product code
- 19049
- State
- current
- Status
- N/A
- Product code detail
- 19049 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species
Manufacturer (製造商)
- Name
- Oxoid Ltd.Oxoid Ltd.
- Country
- United Kingdom英国
- Address
- Wade Road, Basingstoke, RG24 8PW, United Kingdom韦德路, 贝辛斯托克, RG24 8PW, 英国
Authorised representative (AR)
- Name
- Thermo Fisher Scientific (Hong Kong) Limited赛默飞世尔科技(香港)有限公司
- Phone
- 31077600
Regulatory timeline
- Registration date
- March 22, 2023
- Expiry date
- March 22, 2028
Product models
PathoDxtra Disposable Cards (DR0720G), PathoDxtra Extraction Reagents (DR0709M), PathoDxtra Positive Control (DR0707G), PathoDxtra Strep Group A Latex (DR0701G), PathoDxtra Strep Group B Latex (DR0702G), PathoDxtra Strep Group C Latex (DR0703G), PathoDxtra Strep Group D Latex (DR0704G), PathoDxtra Strep Group F Latex (DR0705G), PathoDxtra Strep Group G Latex (DR0706G), PathoDxtra Strep Grouping Kit (DR0700M), PathoDxtra Strep Grouping Reagent Set (DR0710M)
PathoDxtra 一次性卡 (DR0720G), PathoDxtra 提取试剂 (DR0709M), PathoDxtra 阳性对照 (DR0707G), PathoDxtra 链球菌 A 组乳胶 (DR0701G), PathoDxtra 链球菌 B 组乳胶 (DR0702G), PathoDxtra 链球菌 C 组乳胶 (DR0703G), 病理 Dxtra 链球菌 D 组乳胶 (DR0704G), 病理 Dxtra 链球菌 F 组乳胶 (DR0705G), 病理 Dxtra 链球菌组 G 乳胶 (DR0706G), 病理 Dxtra 链球菌分组试剂盒 (DR0700M), 病理 Dxtra 链球菌分组试剂组 (DR0710M)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、细菌、链球菌属