240437
IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta
体外诊断检测试剂/试剂盒, 免疫测定, 妊娠激素, 人绒毛膜促性腺激素, β
Beckman Coulter, Inc.·C·Hong Kong MDACS·Registered September 24, 2024
Device overview
- Risk class
- C
- Product code
- 19124
- State
- current
- Status
- N/A
- Product code detail
- 19124 IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta
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南克雷默大道,布雷亚,加利福尼亚州,92821,美国
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 Total βhCG (5th IS) (Reagent Pack) (A85264, C28645), Access Total βhCG (5th IS) (Calibrator) (B11754)
Access 总 βhCG(第 5 个 IS)(试剂包)(A85264、C28645)、Access 总 βhCG(第 5 个 IS)(校准品)(B11754)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta. 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, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta
產品資訊： 体外诊断检测试剂/试剂盒, 免疫测定, 妊娠激素, 人绒毛膜促性腺激素, β