Roche immunoassay anti-Mullerian hormonal test reagent - Taiwan Registration e01f6a81bc507f959c11c1ff742cded6
Access comprehensive regulatory information for Roche immunoassay anti-Mullerian hormonal test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number e01f6a81bc507f959c11c1ff742cded6 and manufactured by ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Product Details
This product uses electrochemiluminescence immunoassay (ECLIA) with cobas e 411, cobas e 601, cobas e 602, cobas e 801 immunoanalyzer to quantitatively detect anti-Mullerian hormons in human serum and plasma in vitro. Clinical and laboratory results of anti-mullerian hormone can be used to assess ovarian follicle stocks and predict responses to controlled ovarian stimulation (COS). In addition, the anti-muller hormone (in pmol/L) test, together with body weight, was used to establish Ferring Pharmaceutical's personalized daily dose adjustment of human recombinant follitropin hormone (rFSH) follitropin delta (as per Ferring Pharma's current prescription information) for women with multiple follicles under the development of controlled ovarian stimulation, who received an assisted reproductive technology program, under stimulation to develop multiple follicles.
A Clinical chemistry and clinical toxicology
A.9999 Miscellaneous ;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Apr 20, 2022
Apr 20, 2027