Reagents, 2019-Novel Coronavirus Nucleic Acid
Who Makes This Device Type in China?
2 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Fujian, Guangdong and Hunan, and 2 other provinces.
- Hochuen Medical Technology Co., Ltd. Guangdong, contract manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd. Jiangsu
- Sansure Biotech Inc. Hunan
- Xiamen Zeesan Biotech Co., Ltd. Fujian
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is This Device?
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens.
What Is FDA Product Code QJR?
Reagents, 2019-Novel Coronavirus Nucleic Acid is FDA product code QJR, 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 Do the Recalls Say?
The FDA has recorded 40 recalls under this product code since 2020. None was by a company in China. 7 are Class I, the most serious grade.
The root causes the FDA records most often are Device Design (7), Process control (4) and Nonconforming Material/Component (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.