Wondfo Biotech's Fentanyl Tests Are Approved for Sale in US
Tang Shihua
DATE:  Aug 19 2024
/ SOURCE:  Yicai
Wondfo Biotech's Fentanyl Tests Are Approved for Sale in US Wondfo Biotech's Fentanyl Tests Are Approved for Sale in US

(Yicai) Aug. 19 -- Wondfo Biotech said the Chinese biotechnology company has obtained regulatory approval to sell four fentanyl tests in the United States.

Wondfo Biotech received a notice from the Food and Drug Administration that its tests to detect fentanyl in urine have been cleared for the US market, the Guangzhou-based firm announced on Aug. 16. Two are over-the-counter tests and two are for professional institutions, it added.

The products are self-developed by Wondfo Biotech and have a detection threshold of 1 nanogram per milliliter, with high sensitivity, easy operation, and fast results, according to the company. After obtaining the FDA's 510(k) clearance, they can be sold without prescription in e-commerce platforms, pharmacies, and supermarkets in the US or countries that recognize the clearance, it added.

The approval of the fentanyl tests can further enrich Wondfo Biotech's product range, better meet and expand the global testing market demand at all levels, and will likely improve the firm's revenue and overseas business expansion, the company pointed out.

Shares of Wondfo Biotech [SHE: 300482] fell 0.9 percent to CNY23.38 (USD3.27) apiece as of lunch break in Shenzhen today, after earlier dropping by as much as 1.7 percent.

Editor: Martin Kadiev

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Keywords:   Approved for Sale,FDA Approved,US Market,Fentanyl Urine Testing Kit,In Vitro Diagnostics Products Supplier,Wondfo Biotech