220039
IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
体外诊断 测试试剂/试剂盒、免疫测定、维生素、D 代谢物、25-羟基维生素 D
Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered July 24, 2024
Device overview
- Risk class
- B
- Product code
- 19142
- State
- current
- Status
- N/A
- Product code detail
- 19142 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
Manufacturer (製造商)
- Name
- Beckman Coulter, Inc.Beckman Coulter, Inc.
- Country
- United States美国
- Address
- 250 South Kraemer Blvd. Brea, California, CA 92821, USA250南克雷默大道布雷亚,加利福尼亚州,CA 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
- July 24, 2024
- Expiry date
- February 08, 2027
Product models
Access 25(OH) Vitamin D Total (Reagent Pack) (A98856, B24838, C28646), Access 25(OH) Vitamin D Total (Calibrators) (A98857, B24839)
Access 25(OH) 维生素 D 总量(试剂包)(A98856、B24838、C28646)、Access 25(OH) 维生素 D 总量(校准品)(A98857、B24839)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D. 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, Vitamin, D Metabolite, 25-Hydroxyvitamin D
產品資訊： 体外诊断 测试试剂/试剂盒、免疫测定、维生素、D 代谢物、25-羟基维生素 D