240424
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone
体外诊断检测试剂/试剂盒,免疫测定,生育激素,黄体生成素
Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered September 24, 2024
Device overview
- Risk class
- B
- Product code
- 19117
- State
- current
- Status
- N/A
- Product code detail
- 19117 IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing 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 hLH (33510), Access hLH Calibrators (33515)
Access hLH (33510), Access hLH 校准器 (33515)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing 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, Luteinizing Hormone
產品資訊： 体外诊断检测试剂/试剂盒,免疫测定,生育激素,黄体生成素