240336
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125
体外诊断 测试试剂/试剂盒、免疫测定、肿瘤标志物、碳水化合物抗原 CA 125
Beckman Coulter, Inc.·C·Hong Kong MDACS·Registered August 08, 2024
Device overview
- Risk class
- C
- Product code
- 19104
- State
- current
- Status
- N/A
- Product code detail
- 19104 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125
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
- August 08, 2024
- Expiry date
- August 07, 2029
Product models
Access OV Monitor (Reagent Pack) (386357), Access OV Monitor (Calibrators) (386358)
Access OV 监视器(试剂包) (386357), Access OV 监视器(校准器) (386358)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125. 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, Tumor Marker, Carbohydrate Antigen CA 125
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、肿瘤标志物、碳水化合物抗原 CA 125