Covid-19 Multi-Analyte Antigen Device
Which Manufacturers in China Make This?
5 of the 7 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Zhejiang, Anhui and Beijing, and 2 other provinces.
- Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Andon Health Co., Ltd. Tianjin, contract manufacturer
- BD Rapid Diagnostics (Suzhou) Co., Ltd.
- Biohit Healthcare (Hefei) Co., Ltd. Anhui, contract manufacturer
- Core Technology Co., Ltd. Beijing, contract manufacturer
- Guangzhou Wondfo Biotech Co., Ltd. Guangdong, contract manufacturer
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is It?
A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.
How Is QMN Classified?
Covid-19 Multi-Analyte Antigen Device is FDA product code QMN, not classified.
What Does It Take to Sell It in the United States?
This code was created for emergency use authorisation during the COVID-19 public health emergency; sale under it depended on the authorisation, not on a standard premarket submission.
What Has Gone Wrong With It?
The FDA has recorded 7 recalls under this product code since 2020. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (3), Device Design (1) and Incorrect or no expiration date (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.