240340
IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody
体外诊断 检测试剂/试剂盒、免疫分析、自身免疫、甲状腺、过氧化物酶抗体
Beckman Coulter, Inc.·B·Hong Kong MDACS·Registered August 08, 2024
Device overview
- Risk class
- B
- Product code
- 20098
- State
- current
- Status
- N/A
- Product code detail
- 20098 IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody
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 TPO Ab (Reagent Pack) (A12985), Access TPO Ab (Calibrators) (A18227)
接触 TPO 抗体(试剂包) (A12985), 接触 TPO 抗体(校准品) (A18227)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody. 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, Autoimmune, Thyroid, Peroxidase Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、免疫分析、自身免疫、甲状腺、过氧化物酶抗体