IVD China last week: Wondfo, Andon, Bioperfectus, BioMérieux, and Waters

Wondfo respiratory home self-test OTC products receives U.S. FDA EUA

Recently, Wondfo USA Co., Ltd, a wholly owned subsidiary of Wondfo, received notification from the U.S. Food and Drug Administration (FDA) that the Wondfo USA's WELLlife™ COVID-19 / Influenza A&B Home Test for the SARS-COV-2 viruses, influenza A virus, and influenza B virus, has obtained Emergency Use Authorization from FDA (EUA240011).

Based on colloidal gold immunochromatography technology, Wondfo Respiratory Home Self-Test OTC product is easy to operate, with a single addition of samples, and after 10 minutes, three results can be produced at the same time. It is characterized by a long detection window and rapid results, and only requires an anterior nasal sample, which can be qualitatively detected and differentiated within 5 days of the onset of symptoms.

Andon respiratory home self-test OTC products receives U.S. FDA EUA

On May 8, iHealth Labs Inc., the U.S. subsidiary of Andon Health Co., Ltd. was granted Emergency Use Authorization (EUA230053) by the U.S. Food and Drug Administration (FDA) for its SARS-COV-2 viruses, influenza A virus, and influenza B virus Home Test kit. The authorization allows the product to be sold in the U.S. and in countries that recognize the U.S. EUA.

It can be used as a tool to differentiate between the SARS-COV-2 viruses and influenza A and B viruses, making it easier for individuals and families to administer targeted treatments. The Kit product can be self-administered by the individual who collects a prenasal swab and produces results in 15 minutes. The product is available without a prescription and is sold through e-commerce, drugstores, and supermarkets in the U.S., which is expected to generate sales revenue for the Company in the future. The FDA EUA is a further expansion of the company's core strategy and enriches the company's product line in the IVD field.

Bioperfectus recently obtained the medical device registration certificate of dengue virus NS1 antigen detection kit

On May 10, Bioperfectus announced the company recently received the medical device registration certificate issued by National Medical Products Administration (NMPA), the product name is dengue virus NS1 antigen detection kit (colloidal gold method), the kit is used for qualitative detection of human serum or plasma samples of dengue virus NS1 antigen.

BioMérieux Microbial Mass Spectrometry adds new members to its portfolio

On May 11, bioMérieux announced that VITEK MS PRIME, a fully automated microbial mass spectrometry identification system, has recently been approved for marketing by National Medical Products Administration (NMPA). The product utilizes matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS for short) to identify clinically isolated microorganisms (bacteria and fungi).

Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is an important part of a total sepsis solution that aims to provide the lowest inhibitory concentration sensitivity results within 48 hours for all sepsis patients, and the newly launched VITEK® MS The newly launched VITEK® MS PRIME fully continues the reliability of VITEK® MS in terms of database and algorithms, and at the same time improves the experience of the operation process, more efficiently realizes the interface with the LIS classification report and the VITEK® 2 drug sensitization process, which saves manpower, improves the TAT, and supports the clinic in shifting from empirical treatment to targeted treatment earlier.

Debut of Waters Liquid Mass Spectrometry System

On May 8, Waters Corporation held a grand ceremony in Shanghai to announce the launch of its Chinese Mass Spectrometry series of high-end mass spectrometry products, announcing that a number of Chinese liquid chromatography and mass spectrometry products will be launched in the market this month. These products further expand Waters' portfolio of localized products for the Chinese market, including the Waters ArcTM HPLC high performance liquid chromatography (HPLC) system, which has already been successfully localized.

The localized products released this time cover Waters' classic and high-end series, which can be widely used in many fields such as drug R&D and quality control, food safety and environmental testing. For liquid chromatography, ACQUITYTM UPLCTM I-Class PLUS, ACQUITYTM UPLCTM H-Class PLUS and the new ACQUITYTM Premier system, which are the most representative ultra-high performance liquid chromatography (UHPLC) series of Waters, were launched. For mass spectrometry, four triple quadrupole mass spectrometry products including XevoTM TQ-S cronos, XevoTM TQ-S micro, XevoTM TQ-XS and the new high-end model XevoTM TQ Absolute were introduced. These products are designed to provide domestic users with more flexible liquid-mass spectrometry system options to meet the different needs of various application scenarios. It is worth mentioning that the locally manufactured products maintain the same global quality standards in terms of technology and quality, and the first batch will be delivered in May this year.