CA 125 Quantitative Testing Control Kit - Vietnam Registration 2403226ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403226ĐKLH/BYT-HTTB
000.00.04.G18-210719-0007
IMMULITE/IMMULITE 1000 OM-MA (Label Name: IMMULITE/IMMULITE 1000 Systems OM-MA (CA125))
10380969, LKOP1
Technical Details
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
Nov 02, 2024