240423
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
体外诊断 测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素
Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered September 24, 2024
Device overview
- Risk class
- B
- Product code
- 19116
- State
- current
- Status
- N/A
- Product code detail
- 19116 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
Manufacturer (製造商)
- Name
- Beckman Coulter, Inc.Beckman Coulter, Inc.
- Country
- United States美国
- Address
- 250 South Kraemer Blvd., Brea, California, 92821 USA250 South Kraemer Blvd., Brea, California, 92821 USA
Authorised representative (AR)
- Name
- Beckman Coulter Hong Kong Limited贝克曼库尔特香港有限公司
- Phone
- 28147431
Regulatory timeline
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
Product models
Access hFSH (33520), Access hFSH Calibrators (33525)
访问 hFSH (33520),访问 hFSH 校准品 (33525)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone. 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, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素