ZJ Bio-Tech obtains Class III medical device registration certificate for monkeypox virus nucleic acid detection kit

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ZJ Bio-Tech announced that its monkeypox virus nucleic acid detection kit, using fluorescent PCR method, has obtained a national Class III medical device registration certificate, valid from August 17, 2026 to August 16, 2031. The product is mainly used for in vitro qualitative detection of monkeypox virus nucleic acid in skin lesion samples from suspected monkeypox cases. In the first quarter of 2026, ZJ Bio-Tech achieved revenue of 25.42 million yuan and a net loss attributable to the parent company of 25.51 million yuan.

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Shanghai ZJ Bio-Tech Co. Ltd. A
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Obtained Class III medical device registration for monkeypox virus nucleic acid detection kit, enabling product commercialization.