Vietnam MOH registration 2403226ĐKLH/BYT-HTTB

CA 125 Quantitative Testing Control Kit

VN: Bộ thuốc thử, chất hiệu chuẩn xét nghiệm định lượng CA 125

Vietnam·Risk Class TTBYT Loại C·IMMULITE/IMMULITE 1000 OM-MA (Label Name: IMMULITE/IMMULITE 1000 Systems OM-MA (CA125))·Siemens Healthcare Diagnostics Products Limited·Registered Nov 02, 2024

Registration details

Analysis ID: 2403226ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210719-0007
Product Type: IMMULITE/IMMULITE 1000 OM-MA (Label Name: IMMULITE/IMMULITE 1000 Systems OM-MA (CA125))
Product Code: 10380969, LKOP1

Company information

Manufacturer: Siemens Healthcare Diagnostics Products Limited
Manufacturer Country: UNITED KINGDOM
Product Owner: Siemens Healthineers
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: To be used in in vitro diagnostic with the IMMULITE and IMMULITE 1000 Analyzers - to measure the quantitative concentration of the CA125 antigen in serum, as a supportive measure in monitoring the response to treatment in patients with ovarian carcinoma and in the detection of residual ovarian carcinoma in patients who have undergone primary treatment and are being considered for re-examination diagnostic procedures.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for CA 125 Quantitative Testing Control Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403226ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Products Limited. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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