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Overview of IVD test kit manufacturer. |
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For one-step hCG Rapid tests and LH Ovulation test , we have passed the TUV inspection and got CE certifcates, and is also covered by our ISO 13485 certifacte. With CE 0123 mark on the hCG pregnancy kit and LH ovulation test kit, all the three styles of our hCG tests and LH tests, i.e. hCG urine Cassettes, hCG urine strips and hCG urine midstreams, are ready to sell to EU OTC market.
For FSH menopause rapid tests, we also have three formats, i.e. strip, cassette and midstream. For these one-step fertility tests, we have reached the ISO 13485 standard, and always abide by this standard in our producing process. By preparing all the needed documents, we are printing CE mark on the package of FSH test kits, and the products are sold to IVD professional market in European Union (EU) countries.
We can provide CE fertility tests, that is rapid HCG tests, rapid LH tests, rapid FSH tests and rapid TORCH test (also single cassette of CMV test, HSV-1 test, HSV-2 test, RV test and TOXO test) under our NOVAtest® package, and also would like to supply testing kits in OEM packages, such as private labeling, product molding. |
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