200378

IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

体外诊断检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原

Beckman Coulter, Inc.·C·Hong Kong MDACS·Registered August 08, 2024

Device overview

Risk class: C
Product code: 18127
State: current
Status: N/A
Product code detail: 18127 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen

Manufacturer (製造商)

Name: Beckman Coulter, Inc.
Beckman Coulter, Inc.
Country: United States
美国
Address: 250 South Kraemer Blvd., Brea, California, 92821, USA
250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: November 18, 2025

Product models

Access Hybritech p2PSA (Reagent Pack) (A49752), Access Hybritech p2PSA (Calibrators) (A49753), Access Hybritech p2PSA (QC) (A56934), Access Hybritech PSA (Reagent Pack) (37200), Access Hybritech PSA (Calibrators) (37205), Access Hybritech PSA (QC) (37209), Access Hybritech PSA (Diluent) (37206), Access Hybritech PSA (Falcon 2x100) (C22845), Access Hybritech free PSA (Reagent Pack) (37210, C22846), Access Hybritech free PSA (Calibrators) (37215), Access Hybritech free PSA (QC) (37219)

Access Hybritech p2PSA(试剂包) (A49752), Access Hybritech p2PSA (校准品) (A49753), Access Hybritech p2PSA (QC) (A56934), Access Hybritech PSA (试剂包) (37200), Access Hybritech PSA (校准品) (37205), Access Hybritech PSA (QC) (37209), Access Hybritech PSA (稀释剂) (37206), Access Hybritech PSA (Falcon 2x100) (C22845), Access Hybritech free PSA(试剂包) (37210, C22846), Access Hybritech free PSA (校准器) (37215), 访问 Hybritech 免费 PSA (QC) (37219)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen. 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, Enzyme, Prostate Specific Antigen

產品資訊： 体外诊断检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原