Coronavirus Antigen Detection Test System.
Who Makes This Device Type in China?
5 of the 12 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Zhejiang and Beijing, and 4 other provinces.
- Andon Health Co., Ltd. Tianjin, contract manufacturer
- Beijing Hotgen Biotech Co., Ltd. Beijing
- Biohit Healthcare (Hefei) Co., Ltd. Anhui, contract manufacturer
- Bioteke Corporation (Wuxi) Co., Ltd. Jiangsu
- Core Technology Co., Ltd. Beijing, contract manufacturer
- Hangzhou Laihe Biotech Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Biotest Biotech Co., Ltd. Zhejiang, contract manufacturer
- Phase Scientific (Shenzhen) Company Limited Guangdong
- Shenzhen Watmind Medical Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Yang Biotech Co., Ltd. Guangdong, contract manufacturer
- Xiamen Boson Biotech Co., Ltd. Fujian
- Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer
What Is This Device?
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
How Is QKP Classified?
Coronavirus Antigen Detection Test System. is FDA product code QKP, 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 47 recalls under this product code since 2020. 2 were by a company in China. 20 are Class I, the most serious grade.
The root causes the FDA records most often are No Marketing Application (21), Device Design (3) and Incorrect or no expiration date (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.