241050
IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
体外诊断检测试剂/试剂盒, 临床化学, 总蛋白质, 脑脊液
Roche Diagnostics GmbH·B·Hong Kong MDACS·Registered September 24, 2024
Device overview
- Risk class
- B
- Product code
- 17294
- State
- current
- Status
- N/A
- Product code detail
- 17294 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
Manufacturer (製造商)
- Name
- Roche Diagnostics GmbHRoche Diagnostics Gmbh
- Country
- Germany德国
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GermanySandhofer Strasse 116, 68305 曼海姆, 德国
Authorised representative (AR)
- Phone
- 24813387
Regulatory timeline
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
Product models
Elecsys Total-Tau CSF (08846685190, 08846634190), PreciControl Total-Tau (07357028190), CalSet Total-Tau (07357010190)
Elecsys 总 Tau 钙 CSF (08846685190、08846634190)、PreciControl 总 Tau 钙 (07357028190)、CalSet 总 Tau 钙 (07357010190)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid. 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, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
產品資訊： 体外诊断检测试剂/试剂盒, 临床化学, 总蛋白质, 脑脊液