240341
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin
体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌红蛋白
Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered August 08, 2024
Device overview
- Risk class
- B
- Product code
- 17314
- State
- current
- Status
- N/A
- Product code detail
- 17314 IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin
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 Myoglobin (Reagent Pack) (973243), Access Myoglobin (Calibrators) (973244)
Access Myoglobin(试剂包)(973243),Access Myoglobin(校准品)(973244)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin. 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, Cardiac Marker, Protein, Myoglobin
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌红蛋白